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

Sponsor
Lo.Li.Pharma s.r.l
Study ID
NCT05448365
Status
Recruiting
Apply to this trial

Conditions

  • D-chiro-inositol
  • Epigallocatechin Gallate
  • Inositol
  • Uterine Fibroids
  • Vitamin B6
  • Vitamin D

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol — DIETARY_SUPPLEMENT
    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 — DIETARY_SUPPLEMENT
    Maltodextrines

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Aug 2025
Primary completion
Mar 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: EGCG, Vit D, DCI, Vit B6
    Women with uterine fibroids randomized to treatment group
  • Placebo Comparator: Placebo
    Women with uterine fibroids randomized to placebo group

Primary Outcome Measure

Diameter [ Time Frame: 3 months ]

Central Contacts

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