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Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids

RECRUITINGN/ASponsored by Universita di Verona
Actively Recruiting
PhaseN/A
SponsorUniversita di Verona
Started2022-09-15
Est. completion2025-12
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05409872

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 related to uterine fibroids

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

CancerLeiomyoma, Uterine

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