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Loss of funding
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Zinc and green tea supplementation have both been independently studied for supporting immune health during cold and flu-like illness in non-hospitalized patients with clinical trials demonstrating promising but inconsistent results. Combination therapy may offer an improved effect as the antioxidant compounds found in green tea have been shown to increase cellular zinc concentrations thereby inhibiting viral replication. This study seeks to evaluate the effect of combination supplementation using established doses of zinc and green tea extract on symptom duration and severity from cold and flu-like illness, including COVID-19, in adult community patients enrolled in a randomized placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zinc-green tea extract-ascorbic acid | Experimental | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. |
|
| Placebo | Placebo Comparator | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc-green tea extract-ascorbic acid | Drug | Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Recovered From Cold and Flu-like Symptoms | Recovery is defined as achieving a daily total symptom severity score of 0 or 1 within 7 days using an established 12 symptom scoring system, with a severity score ranging from 0-absent to 3-very severe for each symptom assessed (max of 36 points possible; higher scores indicate a greater severity of symptoms) | 7 days of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Self-reported Adverse Events | Adverse events collected include: nausea, vomiting, indigestion, worsening of shortness of breath or difficulty breathing, allergic reaction including skin rash, and need to seek medical care (e.g. hospitalization or physician visit) for a suspected study drug related adverse effect | 7 days of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
17 patients signed consent forms, but only 14 completed at least one study visit for which efficacy and safety endpoints could be assessed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zinc-green Tea Extract-ascorbic Acid | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid. |
| FG001 | Placebo | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. Placebo: Compounded capsules containing microcrystalline cellulose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zinc-green Tea Extract-ascorbic Acid | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Patients Who Recovered From Cold and Flu-like Symptoms | Recovery is defined as achieving a daily total symptom severity score of 0 or 1 within 7 days using an established 12 symptom scoring system, with a severity score ranging from 0-absent to 3-very severe for each symptom assessed (max of 36 points possible; higher scores indicate a greater severity of symptoms) | Posted | Count of Participants | Participants | 7 days of follow-up |
|
7 days for each study subject
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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 | Zinc-green Tea Extract-ascorbic Acid | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal upset | Gastrointestinal disorders | Systematic Assessment |
Due to loss of funding this trial was stopped prior to achieving goal enrollment. As such, no conclusions can be drawn from results reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Camden | University of Missouri Healthcare | (575) 882-4141 | camdenr@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2023 | Jan 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2023 | Jan 3, 2025 | ICF_001.pdf |
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| Placebo | Drug | Compounded capsules containing microcrystalline cellulose. |
|
| Number of Patients Who Reported Days of Absence and/or Healthcare Visits | Absence includes missed days from work or school and healthcare visits include hospitalization or physician office visit(s) for respiratory viral illness related complications | 7 days of follow-up |
| Placebo |
Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. Placebo: Compounded capsules containing microcrystalline cellulose. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. Placebo: Compounded capsules containing microcrystalline cellulose. |
|
|
| Secondary | Number of Patients With Self-reported Adverse Events | Adverse events collected include: nausea, vomiting, indigestion, worsening of shortness of breath or difficulty breathing, allergic reaction including skin rash, and need to seek medical care (e.g. hospitalization or physician visit) for a suspected study drug related adverse effect | Posted | Count of Participants | Participants | 7 days of follow-up |
|
|
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| Secondary | Number of Patients Who Reported Days of Absence and/or Healthcare Visits | Absence includes missed days from work or school and healthcare visits include hospitalization or physician office visit(s) for respiratory viral illness related complications | Posted | Count of Participants | Participants | 7 days of follow-up |
|
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Placebo | Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. Placebo: Compounded capsules containing microcrystalline cellulose. | 0 | 9 | 0 | 9 | 3 | 9 |
| Allergic Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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