An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorZenchi, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Be female.
Be aged 20-45.
BMI 18.5 - 24.9 kg/m2
Self-reported prior diagnosis of uterine fibroids.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Elix Daily Harmony
Dietary supplementEach 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)
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Elix Cycle Balance & Elix Daily HarmonyExperimental treatment 1 intervention
Trial outcomes
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 24Secondary 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 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zenchi, Inc.
Lead sponsor
Citruslabs
Collaborator
Source ClinicalTrials.gov