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The purpose of this study is to determine how Emergen-C use can improve quality of life (QoL) in a real-world setting to help consumers and healthcare professionals understand the benefits of taking Emergen-C on a routine or daily basis.
This will be a randomized, double-blinded, placebo-controlled clinical trial to evaluate the over-time effects of 12-weeks Emergen-C supplementation on QoL parameters in a real-world setting. This study will be entirely decentralized, and participants will not be required to physically attend any on-site visits. All study data will be collected remotely through a study platform using the participant's personal mobile device, tablet or computer. Sufficient participants will be screened to enroll approximately 300 eligible participants (approximately 150 participants per group) and approximately 240 participants are expected to complete the study (approximately 120 participants per group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergen-C Core Super Orange Powder (Test Product) | Experimental | Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
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| Placebo (Reference Product) | Placebo Comparator | Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergen-C Core Super Orange Powder | Dietary Supplement | A dietary supplement powder containing vitamin C, zinc, vitamin B6, vitamin B12, folate, and manganese. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline and Week 12 |
| Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline and Week 12 |
| Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindus Health Limited | New York | New York | 10017 | United States |
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
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A total of 299 participants were enrolled and randomized into two treatment groups: 149 to the Emergen-C group and 150 to the Placebo group. A total of 146 participants from the Emergen-C group and 147 from the Placebo group completed the study.
This study was conducted at a single center in United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Emergen-C Core Super Orange Powder (Test Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
| FG001 | Placebo (Reference Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Safety population included all randomized participants who had taken at least one dose of their randomized study product. Two participants in Emergen-C group did not take any study product as the treatment package was not delivered. Therefore, there were 147 Emergen-C participants and 150 Placebo participants in the Safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Emergen-C Core Super Orange Powder (Test Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
| BG001 | Placebo (Reference Product) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | The modified Intention-To-Treat (mITT) population consisted of all participants who were randomized, completed the Baseline visit, completed at least one-post Baseline MFI domain assessment, and took at least one dose of their allocated randomized product. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emergen-C Core Super Orange Powder (Test Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +441932959500 | ww.clinical-trial-register@haleon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2024 | Feb 4, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2025 | Feb 4, 2026 | SAP_001.pdf |
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| Placebo | Dietary Supplement | To ensure proper blinding, the placebo was formulated to be indistinguishable from Emergen-C in taste, appearance, and other sensory characteristics. The placebo therefore contained fructose, and the electrolytes potassium, magnesium, calcium, and sodium. |
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| Baseline and Week 12 |
| Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms. | Baseline and Week 12 |
| Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline and Week 12 |
| Baseline, Week 4 and Week 8 |
| Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline, Week 4 and Week 8 |
| Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline, Week 4 and Week 8 |
| Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline, Week 4 and Week 8 |
| Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | Baseline, Week 4 and Week 8 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | Baseline, Weeks 4, 8 and 12 |
| Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support | Participants answered 2 QoL questions related to Family support domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life. | Baseline, Weeks 4, 8 and 12 |
| Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience | Participants answered 2 QoL questions related to resilience domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life. | Baseline, Weeks 4, 8 and 12 |
| Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind | Participants answered 2 QoL questions related to 'Ability to relax and unwind' domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life. | Baseline, Weeks 4, 8 and 12 |
| Physician Decision |
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| Study Treatment Package was not delivered |
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Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Emergen-C Core Super Orange Powder (Test Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
| OG001 | Placebo (Reference Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. |
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| Primary | Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Primary | Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Primary | Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Primary | Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 and Week 8 |
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| Secondary | Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 and Week 8 |
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| Secondary | Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 and Week 8 |
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| Secondary | Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 and Week 8 |
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| Secondary | Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8 | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 and Week 8 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition | The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support | Participants answered 2 QoL questions related to Family support domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience | Participants answered 2 QoL questions related to resilience domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| Secondary | Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind | Participants answered 2 QoL questions related to 'Ability to relax and unwind' domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life. | mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4, 8 and 12 |
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| 0 |
| 147 |
| 0 |
| 147 |
| 3 |
| 147 |
| EG001 | Placebo (Reference Product) | Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. | 0 | 150 | 0 | 150 | 8 | 150 |
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment |
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| FREQUENT BOWEL MOVEMENTS | Gastrointestinal disorders | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | Systematic Assessment |
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| PSYCHOMOTOR HYPERACTIVITY | Nervous system disorders | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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