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

Last updated: March 6, 2025
Sponsor: Lo.Li.Pharma s.r.l
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Fibroids

Desmoid Tumors

Sarcoma (Pediatric)

Treatment

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

Placebo

Clinical Study ID

NCT05448365
DELPHYS PLUS
  • Ages 30-40
  • Female

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 Criteria

Inclusion

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

Exclusion Criteria:

  1. BMI>30

  2. currently pregnant or breastfeeding

  3. diabetic

  4. suspect of malignancy

  5. diagnosis of cancer

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • Ospedale Dario camberlingo

    Francavilla Fontana, Puglia 72021
    Italy

    Active - Recruiting

  • Ospedale Veris Delli Ponti

    Scorrano, Puglia 73020
    Italy

    Site Not Available

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