Actively Recruiting
An Open-Label, Single-Group Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
Led by Zenchi, Inc. · Updated on 2025-09-12
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zenchi, Inc.
Lead Sponsor
C
Citruslabs
Collaborating Sponsor
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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants take two investigational herbal supplements daily to evaluate their effect on fibroid-related symptoms.
Multiple visits at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Trial Site Locations
Total: 1 location
1
Citruslabs
Las Vegas, Nevada, United States, 89118
Actively Recruiting
Research Team
P
Patrick Renner, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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