Status:
RECRUITING
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
Lead Sponsor:
Universita di Verona
Conditions:
Leiomyoma, Uterine
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 on symptoms r...
Detailed Description
A randomized controlled trial aimed to evaluate the efficacy of a combination of Epigallocatechin gallate, vitamin D3, D-Chiro-inositol, and vitamin B6 as a treatment for uterine fibroids. The clinica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05409872
Start Date
September 15 2022
End Date
December 1 2025
Last Update
March 4 2025
Active Locations (1)
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1
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, Italy, 37125