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NCT05875233 · ClinicalTrials.gov registry record · NA
A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
A NA study of Polycystic Ovary Syndrome, sponsored by Zenchi.
- Active
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05875233: Active NA study of Polycystic Ovary Syndrome, sponsored by Zenchi.
NCT05875233 is a NA study of Polycystic Ovary Syndrome that is active but no longer recruiting, run by Zenchi. The registered enrollment target is 70 participants, below the 17,256-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05875233, a NA study of Polycystic Ovary Syndrome, is active but no longer recruiting, sponsored by Zenchi.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a virtual, open-label, 2-armed study that will last 6 months. All participants will take the supplements daily and complete questionnaires at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24 (study may be concluded at week 20 if results are seen earlier). The study will involve 70 participants with polycystic ovary syndrome (PCOS), 35 who are on hormonal birth control, and 35 who are not. A subgroup of 20 participants from the non-birth control group, who experience hormonal acne/frequent hormonal breakouts will provide photographs of the face for expert skin grading at baseline, week 12, week 20, and week 24 (if the study is continued until week 24). Questionnaires will be used to monitor changes in the menstrual cycle (regularity, frequency, predictability), bloating, fluid retention, weight gain, mood (mood swings, anxiety, mental clarity/focus, brain fog), pain, fatigue, acne, facial/bodily hair, and sleep quality. Expert skin grading will be carried out by a dermatologist to monitor changes in acne and skin clarity indicative of systemic effects of androgen excess. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
Conditions Studied
Interventions
- OTHER Elix Daily Harmony
- OTHER Elix Cycle Balance
Study Locations (1)
California
- Citruslabs - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-04-13 |
| Est. Completion | 2024-08-30 |
| Phase | NA |
What the registry record for NCT05875233 still lists
NCT05875233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 17,256-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Polycystic Ovary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Elix Daily Harmony is the first listed.
NCT05875233 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05875233 about?
NCT05875233 is a clinical study titled "A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome". This is a virtual, open-label, 2-armed study that will last 6 months. All participants will take the supplements daily and complete questionnaires at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24 (study may be concluded at week 20 if results are seen earlier). The study will involve 70 p...
What is the current status of trial NCT05875233?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2023-04-13. Estimated completion is 2024-08-30.
What conditions does trial NCT05875233 study?
This clinical trial studies the following conditions: Polycystic Ovary Syndrome.
What interventions are being tested in trial NCT05875233?
The interventions under investigation include: Elix Daily Harmony (OTHER), Elix Cycle Balance (OTHER).
Who is sponsoring clinical trial NCT05875233?
This trial is sponsored by Zenchi, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05875233 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05875233's enrollment target sits among peer trials
70 16th of 30 higher than 15 of 30 other Polycystic Ovary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Polycystic Ovary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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