NCT07078682 · Zenchi, Inc.
An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
What this study is about
This is a 24-week, single-treatment group$1, where both patients and doctors know the treatment given, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 chronic disease.
- Self-reported moderate to severe discomfort during menstruation, related to pelvic cramps, 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 three months, and experiences a menstrual cycle with a period.
- If taking other oral over-the-counter supplements or herbal remedies, has been consistently taking these for at least three months prior to starting the study, and is willing to maintain this routine for the study duration.
- Willing to refrain from introducing any products or any new forms of medication or supplements for the study duration.
- Willing to refrain from any other dietary supplements or herbal remedies targeting the 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 of the 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 cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise).
- If using any other interventions, such as massage, chiropractic medicine, or acupuncture, agrees not to increase or decrease the number of these other interventions during the study period.
- Resides in the United States.
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 ketogenic diets.
- Anyone who has experienced significant weight loss in the past three months prior to study participation.
- Unwilling to stop the use of any medication or herbal remedies/supplements that can affect the menstrual cycle.
- Anyone with pre-existing chronic conditions that would prevent participants from adhering 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 at any 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 thyroid disorders), 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, or other.
- 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 fatigue syndrome.
- Hysterectomy, myomectomy, or bilateral salpingo-oophorectomy or other gynecological medical or surgical treatment in the last 6 months.
- History of an abnormal pap smear.
- History of neoplasia of gynecological origin and/or existence of uterine malformations.
- Chronic urinary tract infections or diagnosed functional gastrointestinal conditions like IBS, IBD, Crohn's disease, or ulcerative colitis.
- Currently partaking in another research study or will be partaking in any other research 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
Where
- Las Vegas, Nevada
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations