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NCT05145257 · ClinicalTrials.gov registry record · NA
Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
A NA study of Menstrual Pain and PMS, sponsored by Zenchi.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT05145257: Completed NA study of Menstrual Pain and PMS, sponsored by Zenchi.
NCT05145257 is a NA study of Menstrual Pain and PMS that has completed, run by Zenchi. The registered enrollment target is 68 participants, roughly in line with the 67-participant average among 3 other Menstrual Pain trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05145257, a NA study of Menstrual Pain and PMS, has completed, sponsored by Zenchi.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Elix Cycle Balance
Study Locations (1)
California
- Citruslabs - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-01-05 |
| Est. Completion | 2022-05-31 |
| Phase | NA |
What the finished NCT05145257 record still lists
NCT05145257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, roughly in line with the 67-participant average among 3 other Menstrual Pain trials with a reported enrollment target.
The record links to 2 conditions, with Menstrual Pain appearing as the primary indexed condition, and to 1 intervention - of which Elix Cycle Balance is the first listed.
NCT05145257 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05145257 about?
NCT05145257 is a clinical study titled "Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms". 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...
What is the current status of trial NCT05145257?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2022-01-05. Estimated completion is 2022-05-31.
What conditions does trial NCT05145257 study?
This clinical trial studies the following conditions: Menstrual Pain, PMS.
What interventions are being tested in trial NCT05145257?
The interventions under investigation include: Elix Cycle Balance (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05145257?
This trial is sponsored by Zenchi, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05145257 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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