ClinicalTrials.gg
RecruitingNCT07078682Updated Sep 12, 2025

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

An interventional study of Elix Daily Harmony in Uterine Fibroids, Leiomyoma and Menstrual Pain, sponsored by Zenchi, Inc.. Recruiting at 1 site in United States. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Zenchi, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Female
01

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.

02

Conditions studied

  • Uterine Fibroids
  • Leiomyoma
  • Menstrual Pain
03

In context

Leiomyoma

438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.

This study's planned enrollment of 42 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Zenchi, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be female.
  • Be aged 20-45.
  • 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 , 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

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 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 ( > 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Elix Cycle Balance & Elix Daily Harmony

    Participants will receive two investigational herbal supplements daily for 24 weeks.

    Dietary Supplement: Elix Daily Harmony

Interventions

  • Dietary supplementElix Daily Harmony

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Jan 2026, 5 months after the start.

Of 57 interventional studies with no phase under Leiomyoma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2025
First posted
Jul 22, 2025
StartActual
Aug 1, 2025
Primary completionEst.
Jan 2026
CompletionEst.
Jan 2026
Last update
Sep 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07078682
Lead sponsor
Zenchi, Inc.
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Jul 22, 2025
Start date
Aug 1, 2025
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
Sep 12, 2025

Study contacts

Patrick Renner, MSc
Contact
hello@citruslabs.com
4242450284

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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