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Clinical Trials in Italy / NCT05448365
Recruiting Not applicable

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

NCT05448365 · tracked via the Priya Life Science Italy tracker
Sponsor
Lo.Li.Pharma s.r.l
Phase
Not applicable
Started
2022-07-01
Last updated
2026-02-12

Condition(s) studied

Uterine FibroidsD-chiro-inositolInositolEpigallocatechin GallateVitamin DVitamin B6

Investigational drug(s) / intervention(s)

Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositolPlacebo

Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol: The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D

Placebo: Maltodextrines

Study summary

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.

The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Eligibility

Sex
FEMALE
Min age
30 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: 1. uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids 2. eligible for surgery 3. symptoms like menometrorrhagia or pelvic pain Exclusion Criteria: 1. BMI\>30 2. currently pregnant or breastfeeding 3. diabetic 4. suspect of malignancy 5. diagnosis of cancer

Primary outcome measure(s)

  • Diameter — 3 months
    Greater diameter of the diagnosed uterine fibroids

Trial sites (2)

FacilityCityRegionStatus
Ospedale Dario camberlingo Francavilla Fontana Apulia Recruiting
Ospedale Veris Delli Ponti Scorrano Apulia Not Yet Recruiting

More Lo.Li.Pharma s.r.l trials in Italy

Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel Recruiting
The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection. Recruiting

Other trials for the same condition

Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05448365 on ClinicalTrials.gov ↗ ← All trials in Italy