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

Last updated: September 7, 2025
Sponsor: Zenchi, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Menstrual Disorders

Premenstrual Syndrome

Severe Premenstrual Symptom

Treatment

Elix Daily Harmony

Clinical Study ID

NCT07078682
20790
  • Ages 20-45
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be female.

  • Be aged 20-45.

  • BMI 18.5 - 24.9 kg/m2

  • Self-reported prior diagnosis of uterine fibroids.

  • Anyone who is generally healthy - does not live with any uncontrolled chronicdisease.

  • Self-reported moderate to severe discomfort during menstruation, related to pelviccramps, bloating, mood swings, or fatigue.

  • Self-reported menstrual cramps during their cycle, for the past six months minimum.

  • If taking hormonal birth control, has been doing so consistently for at least threemonths, and experiences a menstrual cycle with a period.

  • If taking other oral over-the-counter supplements or herbal remedies, has beenconsistently taking these for at least three months prior to starting the study, andis willing to maintain this routine for the study duration.

  • Willing to refrain from introducing any products or any new forms of medication orsupplements for the study duration.

  • Willing to refrain from any other dietary supplements or herbal remedies targetingthe menstrual cycle during the study period.

  • Willing to refrain from any new vaccines during the 6 month period.

  • Follows a stable, consistent exercise regimen and are willing, for the duration ofthe study, to not decrease or increase the amount of exercise in their regimen.

  • Agrees to refrain from any lifestyle changes that may affect their menstrual cyclefor the duration of the study (for example, getting on or off hormonal birthcontrol, reducing the amount of exercise).

  • If using any other interventions, such as massage, chiropractic medicine, oracupuncture, agrees not to increase or decrease the number of these otherinterventions during the study period.

  • Resides in the United States.

Exclusion

Exclusion Criteria:

  • Does not experience a regular menstrual cycle (21-35 days).

  • Does not experience menstrual cramping.

  • Follows an extreme diet intervention such as dry fasts, water fasts, or ketogenicdiets.

  • Anyone who has experienced significant weight loss in the past three months prior tostudy participation.

  • Unwilling to stop the use of any medication or herbal remedies/supplements that canaffect the menstrual cycle.

  • Anyone with pre-existing chronic conditions that would prevent participants fromadhering to the protocol, including oncological and psychiatric disorders.

  • Anyone with known severe allergic reactions.

  • Anyone with any allergies or sensitivities to any of the study product ingredients.

  • Any women who are pregnant, breastfeeding, or trying to conceive (or who will be atany point during the study period).

  • Anyone unwilling to follow the study protocol.

  • Has stopped, started, or changed hormonal birth control in the past three months.

  • Previous users of Elix Cycle Balance.

  • Anyone who is currently a smoker or has been a smoker in the past 3 months.

  • Anyone who has been diagnosed with the following conditions: PCOS, Endometriosis,PMDD, Adenomyosis, Hashimoto's thyroiditis, Grave's disease (and any other thyroiddisorders), hyperprolactinemia, Cushing's disease, congenital adrenal hyperplasia,anorexia, bulimia, orthorexia, binge eating, any other eating disorder.

  • History of endocrine disorders such as thyroid disorder, Type 1 or 2 diabetes, orother.

  • History of hypertension, hyperlipidemia, or previous venous embolism.

  • Overweight/obesity (BMI > 25 kg/m2).

  • Women with other causes of chronic pelvic pain, including infectious disease,gastrointestinal, psychological disorders, fibromyalgia, and chronic fatiguesyndrome.

  • Hysterectomy, myomectomy, or bilateral salpingo-oophorectomy or other gynecologicalmedical or surgical treatment in the last 6 months.

  • History of an abnormal pap smear.

  • History of neoplasia of gynecological origin and/or existence of uterinemalformations.

  • Chronic urinary tract infections or diagnosed functional gastrointestinal conditionslike IBS, IBD, Crohn's disease, or ulcerative colitis.

  • Currently partaking in another research study or will be partaking in any otherresearch study for the next 24 weeks, or at any point during this study's duration.

  • Consume more than 5 alcoholic drinks per week

  • Had a vaccine in the last 3 months

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Elix Daily Harmony
Phase:
Study Start date:
August 01, 2025
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Citruslabs

    Las Vegas, Nevada 89118
    United States

    Site Not Available

  • Citruslabs

    Las Vegas 5506956, Nevada 5509151 89118
    United States

    Active - Recruiting

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