What is Elix Cycle Balance and Elix Daily Harmony studying for uterine fibroids?

Elix Cycle Balance and Elix Daily Harmony are being studied to see how they affect uterine fibroid-related symptoms and quality of life in women. This open-label study evaluates symptom changes over 24 weeks under the sponsorship of Zenchi, Inc. Participants take these herbal supplements daily while researchers track their experiences.

Who may be eligible for this uterine fibroids clinical trial?

Women aged 20 to 45 with a self-reported diagnosis of uterine fibroids and moderate to severe menstrual discomfort may be eligible. Participants must be generally healthy, follow a stable exercise routine, and live in the United States. Please review eligibility criteria for more details.

Is there any cost to participate in this uterine fibroids clinical trial?

Study-related care, including the herbal supplements and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 20Years - 45Years

FEMALE

ID07078682

Study of Elix Cycle Balance & Elix Daily Harmony Herbal Supplements for Women With Uterine Fibroid Symptoms

Led by Zenchi, Inc. · Updated on 2025-09-12

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two investigational herbal supplements, Elix Cycle Balance and Elix Daily Harmony, on symptoms related to uterine fibroids and the quality of life in women aged 20 to 45. This 24-week, single-arm, open-label virtual study involves 42 participants who have reported moderate to severe menstrual discomfort linked to fibroids. The study aims to understand how these supplements affect symptom severity and health-related quality of life over time. Participants will self-administer Elix Cycle Balance and Elix Daily Harmony daily for 24 weeks. Each morning, about 1-2 hours after their first meal, they will mix and consume 3 droppers full of Elix Daily Harmony and 6 droppers full of Elix Cycle Balance in water at room temperature or warm. There is no placebo or comparison group, and all participants receive the same herbal supplements throughout the study. During the trial, participants will complete validated questionnaires at baseline and at regular intervals Week 4, 8, 12, 16, 20, and 24 to assess the severity of fibroid-related symptoms and changes in quality of life. Researchers will monitor symptom changes and quality of life domains through these scheduled assessments. The total participant involvement lasts 24 weeks, with no additional treatment or follow-up periods beyond this timeframe.

CONDITIONS

Brief Title

An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms

Who Can Participate

Age: 20Years - 45Years

FEMALE

Eligibility Criteria

You may qualify if you...

Be female.
Be aged 20 to 45 years.
Have a BMI between 18.5 and 24.9 kg/m2.
Have a self-reported prior diagnosis of uterine fibroids.
Be generally healthy without uncontrolled chronic diseases.
Experience moderate to severe menstrual discomfort related to pelvic cramps, bloating, mood swings, or fatigue.
Have had menstrual cramps during their cycle for at least the past six months.
If taking hormonal birth control, have used it consistently for at least three months and still have a menstrual period.
If taking other oral over-the-counter supplements or herbal remedies, have used them consistently for at least three months and agree to maintain this routine during the study.
Willing to avoid new medications, supplements, or vaccines during the study period.
Follow a stable, consistent exercise regimen and agree not to change it during the study.
Agree not to make lifestyle changes affecting the menstrual cycle during the study.
Agree not to change other interventions such as massage, chiropractic medicine, or acupuncture during the study.
Reside in the United States.

You will not qualify if you...

Do not have a regular menstrual cycle (21-35 days).
Do not experience menstrual cramping.
Follow extreme diet interventions such as dry fasts, water fasts, or ketogenic diets.
Have experienced significant weight loss in the past three months.
Are unwilling to stop medications or supplements that affect the menstrual cycle.
Have pre-existing chronic conditions that prevent adherence to the protocol, including oncological or psychiatric disorders.
Have known severe allergic reactions or allergies to study product ingredients.
Are pregnant, breastfeeding, or trying to conceive during the study.
Are unwilling to follow the study protocol.
Have changed hormonal birth control in the past three months.
Have previously used Elix Cycle Balance.
Are current or recent smokers (within past 3 months).
Have been diagnosed with certain conditions such as PCOS, Endometriosis, PMDD, Adenomyosis, thyroid disorders, eating disorders, diabetes, hypertension, or chronic pelvic pain causes.
Have had gynecological surgery or abnormal pap smears recently.
Have chronic urinary or gastrointestinal conditions.
Are participating in another research study during this trial.
Consume more than 5 alcoholic drinks per week.
Have had a vaccine in the last 3 months.

Research Team

Patrick Renner, MSc

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Study of Elix Cycle Balance & Elix Daily Harmony Herbal Supplements for Women With Uterine Fibroid Symptoms

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria