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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms.
It is hypothesized that the dietary supplement marketed as "Elix Cycle Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as cramps, bloating, and mood swings.
A total of 65 participants will be recruited for the trial following screening, with the expectation that at least 50 participants will complete the trial. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. The total intervention study period will be 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elix Cycle Balance | Other | Elix Cycle Balance supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elix Cycle Balance | Dietary Supplement | Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance |
| Measure | Description | Time Frame |
|---|---|---|
| Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months] | Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months] | Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months] | Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome. | Baseline, Month 1, Month 2, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Mood Swings. [Time Frame: Baseline to Week 12] | Survey-based assessment (0-5 scale) of changes in mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke, MSc | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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Main recruitment took place between 1/5/2022 - 1/10/2022 when 65 participants were recruited. A further 3 participants were recruited on 01/26/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elix Cycle Balance | Elix Cycle Balance supplement Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elix Cycle Balance | Elix Cycle Balance supplement Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance |
| 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 | Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months] | Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
|
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Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.
All participants were monitored for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Elix Cycle Balance | Elix Cycle Balance supplement Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach upset | Gastrointestinal disorders | Non-systematic Assessment | One participant withdrew from the trial due to stomach upset. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Renner | Citruslabs | 4242450284 | hello@citruslabs.com |
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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 | Nov 9, 2021 | Oct 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2021 | Oct 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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Open-label observational single-group
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| Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3] |
Survey-based assessment (0-5 scale) of changes in anxiety and depression. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. |
| Baseline, Month 1, Month 2, Month 3 |
| Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in acne flare ups. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Headaches. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in headaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Backaches. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in backaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Body Aches. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in body aches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Bloating. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in bloating. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in gastrointestinal issues. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in joint or muscle pain. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in tiredness and fatigue. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Relief From Breast Tenderness. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in breast tenderness. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in appetite and food cravings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Baseline, Month 1, Month 2, Month 3 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Survey-based assessment (0-5 scale) of menstrual symptoms | Mean | Standard Deviation | units on a scale |
|
| Use of over-the-counter NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. | Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome. | Mean | Standard Deviation | Number of painkillers taken per day |
|
| Participants |
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| Primary | Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months] | Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Primary | Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months] | Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome. | Posted | Mean | Standard Deviation | NSAID tablets per day | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Reduction in Mood Swings. [Time Frame: Baseline to Week 12] | Survey-based assessment (0-5 scale) of changes in mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in anxiety and depression. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in acne flare ups. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
|
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| Secondary | Relief From Headaches. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in headaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
|
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| Secondary | Relief From Backaches. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in backaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
|
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|
|
| Secondary | Relief From Body Aches. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in body aches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Relief From Bloating. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in bloating. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in gastrointestinal issues. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in joint or muscle pain. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in tiredness and fatigue. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Relief From Breast Tenderness. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in breast tenderness. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| Secondary | Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3] | Survey-based assessment (0-5 scale) of changes in appetite and food cravings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 2, Month 3 |
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| 0 |
| 68 |
| 0 |
| 68 |
| 7 |
| 68 |
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| Headache | General disorders | Non-systematic Assessment | One participant withdraw from the trial due to headaches. |
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| Personal Issue | Social circumstances | Non-systematic Assessment | One participant withdrew from the trial due to a personal issue unrelated to the product. |
|
| No response | Product Issues | Non-systematic Assessment | Four participants withdrew from the trial as they reported nil effect or response from the product. |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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