A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Zenchi, Inc.

Must be taking: Hormonal birth control

Must not be taking: Menstrual cycle supplements

Disqualifiers: Endometriosis, Uterine fibroids, Reproductive cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves women with PCOS taking a daily supplement. The study will monitor changes in their symptoms like menstrual cycle regularity, acne, and mood over several months. The goal is to see if the supplement helps balance hormones and improve overall well-being.

Do I need to stop taking my current medications to join the trial?

The trial requires participants to stop taking any supplements or medications that target the menstrual cycle. If you are in the hormonal birth control group, you must stay on the same birth control for the study duration. If you are in the non-hormonal birth control group, you must not use hormonal birth control during the study.

What data supports the effectiveness of the drug Elix Cycle Balance, Elix Daily Harmony?

The research highlights the potential benefits of using drug combinations, as they can improve overall effectiveness and decrease toxicity compared to single drugs. This suggests that Elix Cycle Balance and Elix Daily Harmony, as a combination, might work better together than individually, similar to how other drug combinations have shown improved outcomes in various treatments. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for women aged 18-36 with PCOS, who are generally healthy and have a stable lifestyle without plans to change their diet, exercise, or hormonal birth control use. Participants must not be pregnant, attempting pregnancy, smokers, or have certain medical conditions like uncontrolled diseases or recent gynecological treatments.

Inclusion Criteria

I experience symptoms like mood swings, irregular periods, and low energy.

I have been on the same hormonal birth control for 3 months and won't change it for the next 6 months.

I am generally healthy without any uncontrolled chronic diseases.

Exclusion Criteria

Anyone with a history of substance abuse

I have had a hysterectomy or other major female reproductive surgery in the last 6 months.

I have been diagnosed with a specific chronic condition or cancer related to my reproductive or digestive system, or an autoimmune disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Elix Cycle Balance and Daily Harmony supplements daily and complete questionnaires at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24

24 weeks

Virtual check-ins at weeks 4, 8, 12, 16, 20, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Elix Cycle Balance
• Elix Daily Harmony

Trial Overview The study tests Elix Daily Harmony and Cycle Balance supplements on PCOS symptoms over 6 months. It's virtual and open-label with two groups: one using hormonal birth control and the other not. They'll take daily supplements and complete regular questionnaires about menstrual cycle changes, mood swings, acne etc.

Participant Groups

Group I: Group Two: PCOS with No Hormonal Birth Control Active Control 2 Interventions

All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control.

Group II: Group One: PCOS & Hormonal Birth Control Active Control 2 Interventions

All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control.

Who Is Running the Clinical Trial?

Zenchi, Inc.

Lead Sponsor

Trials

3

Recruited

140+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy of disseminated breast cancer. Current status and prospects. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Microdose follicular flare: a viable alternative for normal-responding patients undergoing in vitro fertilization? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Revisiting the isobole and related quantitative methods for assessing drug synergism. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Titrating and evaluating multi-drug regimens within subjects. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Current Methods for Quantifying Drug Synergism. [2021]