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Brief Title: Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
Official Title: Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
Study ID: NCT05409872
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 related to uterine fibroids
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 clinical study is double-blind, neither patients nor investigators know whether the subject receives the combination of Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 or the placebo. After 3 months of treatment, changes in symptoms associated with uterine fibroids, quality of life, and ultrasounds characteristics are compared between the two treatment arms.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology, Verona, , Italy
Name: Stefano Uccella, MD, PhD
Affiliation: AOUI Verona - University of Verona
Role: PRINCIPAL_INVESTIGATOR
Name: Simone Garzon, MD
Affiliation: AOUI Verona - University of Verona
Role: PRINCIPAL_INVESTIGATOR
Name: Pier Carlo Zorzato, MD
Affiliation: AOUI Verona - University of Verona
Role: PRINCIPAL_INVESTIGATOR