NCT07078682 An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
| NCT ID | NCT07078682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zenchi, Inc. |
| Condition | Uterine Fibroids |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-08-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07078682 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 45 Years, studying Uterine Fibroids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07078682 currently recruiting?
Yes, NCT07078682 is actively recruiting participants. Contact the research team at hello@citruslabs.com for enrollment information.
Where is the NCT07078682 trial being conducted?
This trial is being conducted at Las Vegas, United States.
Who is sponsoring the NCT07078682 clinical trial?
NCT07078682 is sponsored by Zenchi, Inc.. The trial plans to enroll 42 participants.