Uterine FibroidsNCT07078682
An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
A study testing Elix Daily Harmony in people with Uterine Fibroids and Leiomyoma, run by Zenchi, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Uterine Fibroids, Leiomyoma, Menstrual Pain
- What is being tested?
- Elix Daily Harmony
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Citruslabs
Las Vegas, Nevada, 89118
Patrick Renner, MSc, 424-245-0284, hello@citruslabs.com
About this study
Official title: An Open-Label, Single-Group Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
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
- Uterine Fibroids, Leiomyoma, Menstrual Pain
- Being tested
- Elix Daily Harmony
- Medical subject headings
- Leiomyoma, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elix Daily HarmonyDietary supplement
Each morning, 1-2 hours after their first meal, they will mix the following into room-temperature or warm water and consume:
Elix Daily Harmony: 3 droppers full (approximately 2.5 mL) Elix Cycle Balance: 6 droppers full (approximately 5.0 mL)
| Study group | Role | What they receive |
|---|---|---|
| Elix Cycle Balance & Elix Daily Harmony | Experimental | Participants will receive two investigational herbal supplements daily for 24 weeks. Receives: Dietary Supplement: Elix Daily Harmony |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in uterine fibroid-related symptom severity
Measured as change in menstrual pain and bleeding volume using the validated Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL) total and subscale scores.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Secondary outcomes (1)
Change in fibroid-related health-related quality of life domains
Measured as change in self-reported scores on UFS-QOL and study-specific questions addressing energy levels, emotional well-being, self-consciousness, sleep quality, and limitations in daily and social activities.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenchi, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078682
- Sponsor's protocol ID
- 20790
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Group Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
- ClinicalTrials.gov ID
- NCT07078682
- Acronym / sponsor ID
- 20790
- Conditions
- Uterine Fibroids, Leiomyoma, Menstrual Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Zenchi, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elix Cycle Balance & Elix Daily Harmony | Experimental | Dietary Supplement: Elix Daily HarmonyParticipants will receive two investigational herbal supplements daily for 24 weeks. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elix Daily HarmonyEach morning, 1-2 hours after their first meal, they will mix the following into room-temperature or warm water and consume: Elix Daily Harmony: 3 droppers full (approximately 2.5 mL) Elix Cycle Balance: 6 droppers full (approximately 5.0 mL) | Dietary supplement | Elix Cycle Balance & Elix Daily Harmony |
Primary outcome
Change in uterine fibroid-related symptom severity
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Measured as change in menstrual pain and bleeding volume using the validated Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL) total and subscale scores.
1 secondary outcome
Change in fibroid-related health-related quality of life domains
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elix Daily Harmony in people with Uterine Fibroids and Leiomyoma, run by Zenchi, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Renner, MSc (4242450284, hello@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in uterine fibroid-related symptom severity (time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.