Elix Supplements for 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two supplements, Elix Cycle Balance and Elix Daily Harmony, to assess their effects on women with polycystic ovary syndrome (PCOS). The goal is to determine if these supplements can alleviate symptoms such as irregular periods, mood swings, and acne. The trial includes two groups: one for participants taking hormonal birth control and another for those who are not. Women diagnosed with PCOS in the last five years and experiencing symptoms like irregular periods or acne may be suitable candidates if they agree to follow the trial guidelines. As an unphased trial, this study provides an opportunity to explore new ways to manage PCOS symptoms.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Elix Cycle Balance and Elix Daily Harmony are generally easy for most people to take. In earlier studies, about 85.7% of participants reported fewer premenstrual and menstrual cramps after using these supplements. Additionally, nearly 90% of participants not on birth control found that these supplements helped regulate their menstrual cycles.

Serious side effects have not been commonly reported, indicating that participants usually don't experience severe issues. However, it's important to remember that research on these supplements continues, so new information could emerge. Consider consulting a healthcare professional before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Elix Cycle Balance and Elix Daily Harmony for treating Polycystic Ovary Syndrome (PCOS) because they offer a natural and holistic approach to managing symptoms. Unlike standard treatments like hormonal birth control and medications such as Metformin, which mainly focus on regulating menstrual cycles or managing insulin resistance, these treatments harness the power of herbal medicine. Elix Cycle Balance and Daily Harmony are unique because they use a blend of traditional Chinese herbs aimed at balancing hormones naturally, potentially reducing side effects associated with synthetic alternatives. This natural approach not only targets hormonal balance but also aims to support overall well-being, making it an intriguing option for those looking for alternative solutions to managing PCOS.

What evidence suggests that this trial's treatments could be effective for PCOS?

Research has shown that Elix Cycle Balance and Daily Harmony might help manage symptoms of polycystic ovary syndrome (PCOS). In this trial, participants will be divided into two groups: one group with PCOS not on hormonal birth control and another group with PCOS regularly taking hormonal birth control. Earlier studies found that about 90% of participants not on birth control experienced more regular menstrual cycles with these supplements. Additionally, over 70% noticed reduced acne and fewer signs of high male hormones, common in PCOS. Many participants also reported fewer menstrual cramps, with 85.7% feeling relief. These findings suggest that these supplements could help many manage PCOS symptoms. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05875233

A Study to Evaluate the Effect of Elix Cycle Balance and ... 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 ...

2. elixhealing.com elixhealing.com/blogs/the-wisdom/elix-second-clinical-study-cycle-balance-daily-harmony-for-pcos?srsltid=AfmBOoptDv4HI7myFUPzQIvGiHEAduGOo1Pw51fwnsG1Ial7PRFNKkOX

Elix's PCOS Clinical Study: How Cycle Balance and Daily ... ~90% of participants who did not take birth control reported that Elix's Cycle Balance and Daily Harmony formulas helped regulate their menstrual cycles. 70%+ ...

3. withpower.com withpower.com/trial/phase-polycystic-ovary-syndrome-3-2023-9237c

A Study to Evaluate the Effect of Elix Cycle Balance and ... This trial involves women with PCOS taking a daily supplement. The study will monitor changes in their symptoms like menstrual cycle regularity, acne, ...

4. elixhealing.com elixhealing.com/pages/elix-cycle-balance-effective-clinical-results?srsltid=AfmBOooZxpE_An55F_CZppCzid8UmgdVOk6ha_8J4xr2TUYSWmqrYqAz

Elix Cycle Balance Clinical Results The study primarily focuses on changes in ovarian function, including menstrual cycle regularity, frequency, and signs of androgen excess, specifically acne and ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/57/NCT05145257/Prot_SAP_000.pdf

Study to evaluate the efficacy of Elix's Cycle Balance and ... It is hypothesized that the dietary supplement marketed as “Elix Cycle Balance” will improve subjective wellbeing in trial participants by ...

6. elixhealing.com elixhealing.com/blogs/the-wisdom/elix-second-clinical-study-cycle-balance-daily-harmony-for-pcos?srsltid=AfmBOopuFyVqKPzFv__RI36QrtYTr2r_OGQ1IUw6mwhKRdivhzJncLpe

Elix's PCOS Clinical Study: How Cycle Balance and Daily ... 85.7% of participants agreed that they had fewer premenstrual and menstrual cramps after taking Elix Cycle Balance and Daily Harmony. 71.4% of participants ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0062250

Polycystic Ovarian Syndrome (PCOS) (DBCOND0062250) A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome, No drug interventions, other, Not Available ...