Actively Recruiting

Phase Not Applicable
Age: 20Years - 45Years
FEMALE
NCT07078682

An Open-Label 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

21 weeks

Total Duration

On this page

Sponsors

Z

Zenchi, Inc.

Lead Sponsor

C

Citruslabs

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants. Participants will self-administer the investigational herbal supplements daily and complete validated questionnaires at scheduled timepoints to assess symptom severity and quality of life.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Be female.
  • Be aged 20-45.
  • 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 experienced menstrual cramps during cycles for at least six months.
  • If using hormonal birth control, have been using it consistently for at least three months and still have menstrual periods.
  • If using other oral over-the-counter supplements or herbal remedies, have been taking them consistently for at least three months and are willing to maintain this during the study.
  • Willing to avoid introducing new products, medications, supplements, or lifestyle changes affecting the menstrual cycle during the study.
  • Willing to avoid any new vaccines during the 6-month study period.
  • Follow a stable exercise routine and agree not to change the amount of exercise during the study.
  • Agree not to change other interventions like massage, chiropractic medicine, or acupuncture during the study.
  • Reside in the United States.
Not Eligible

You will not qualify if you...

  • Do not have a regular menstrual cycle (21-35 days).
  • Do not experience menstrual cramping.
  • Follow extreme diets 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 following the study protocol, including oncological or psychiatric disorders.
  • Have 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 stopped, started, or changed hormonal birth control in the past three months.
  • Have previously used Elix Cycle Balance.
  • Are current smokers or have smoked in the past three months.
  • Have diagnoses of PCOS, Endometriosis, PMDD, Adenomyosis, Hashimoto's thyroiditis, Grave's disease, other thyroid disorders, hyperprolactinemia, Cushing's disease, congenital adrenal hyperplasia, anorexia, bulimia, orthorexia, binge eating, or other eating disorders.
  • Have a history of endocrine disorders such as thyroid disorders or diabetes.
  • Have a history of hypertension, hyperlipidemia, or venous embolism.
  • Have a BMI greater than 25 kg/m2.
  • Have other causes of chronic pelvic pain including infectious diseases, gastrointestinal, psychological disorders, fibromyalgia, or chronic fatigue syndrome.
  • Have had gynecological surgery or treatment in the last 6 months.
  • Have a history of abnormal pap smear, gynecological cancer, or uterine malformations.
  • Have chronic urinary tract infections or diagnosed gastrointestinal conditions like IBS, IBD, Crohn's disease, or ulcerative colitis.
  • Are currently or will be participating in another research study during this study period.
  • 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

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Trial Site Locations

Total: 1 location

1

Citruslabs

Las Vegas, Nevada, United States, 89118

Actively Recruiting

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Research Team

P

Patrick Renner, MSc

CONTACT

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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