Combination treatment for uterine fibroids using vitamins and epigallocatechin gallate
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
This study is testing a combination of vitamins and a natural compound to see if it can help people with uterine fibroids feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universita di Verona Academic / other |
| Locations | 1 site (Verona) |
| Trial ID | NCT05409872 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination of Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 in treating symptoms related to uterine fibroids. It is a randomized, double-blind, single-center controlled trial where participants receive either the treatment or a placebo for three months. The study aims to assess changes in symptoms, quality of life, and ultrasound characteristics of uterine fibroids after the treatment period. Both patients and investigators are unaware of which treatment is administered to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are women with multiple fibroids or a single fibroma of at least 4 cm who are considering surgical options like hysterectomy or myomectomy.
Not a fit: Patients who are pregnant, breastfeeding, or have undergone recent medical treatment for uterine fibroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for managing symptoms of uterine fibroids, potentially reducing the need for surgical interventions.
How similar studies have performed: While the combination of these specific treatments is novel, previous studies have shown some success with individual components in managing uterine fibroids.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for hysterectomy. * Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for myomectomy / uterine arterial embolization. * Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for treatment with magnetic resonance (MR)-guided Focused Ultra-Sound (MrgFUS). Exclusion Criteria: * Pregnancy. * Breastfeeding. * Smoking. * Suspected malignancy. * Patients who have undergone medical treatment for uterine fibroids within the previous three months. * Patients allergic to the components of the product or placebo under study. * Patients who refuse to provide informed consent to participate in the study.
Where this trial is running
Verona
- AOUI Verona - University of Verona - Department of Obstetrics and Gynecology — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Uccella, MD, PhD — AOUI Verona - University of Verona
- Study coordinator: Stefano Uccella, MD, PhD
- Email: stefano.uccella@univr.it
- Phone: 0039 045 812 2720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.