NCT05448365

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2022Jul 2026

Study Start

First participant enrolled

July 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 12, 2026

Status Verified

August 1, 2025

Enrollment Period

3.7 years

First QC Date

July 4, 2022

Last Update Submit

February 10, 2026

Conditions

D-chiro-inositolInositolEpigallocatechin GallateVitamin DVitamin B6Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • Diameter

    Greater diameter of the diagnosed uterine fibroids

    3 months

Secondary Outcomes (4)

  • Volume

    3 months

  • Need for surgery

    3 months

  • pVEGF-R

    3 months

  • Marker of cellular proliferation

    3 months

Study Arms (2)

EGCG, Vit D, DCI, Vit B6

ACTIVE COMPARATOR

Women with uterine fibroids randomized to treatment group

Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

Placebo

PLACEBO COMPARATOR

Women with uterine fibroids randomized to placebo group

Dietary Supplement: Placebo

Interventions

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

EGCG, Vit D, DCI, Vit B6
PlaceboDIETARY_SUPPLEMENT

Maltodextrines

Placebo

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
  • eligible for surgery
  • symptoms like menometrorrhagia or pelvic pain

You may not qualify if:

  • BMI\>30
  • currently pregnant or breastfeeding
  • diabetic
  • suspect of malignancy
  • diagnosis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale Dario camberlingo

Francavilla Fontana, Apulia, 72021, Italy

RECRUITING

Ospedale Veris Delli Ponti

Scorrano, Apulia, 73020, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

epigallocatechin gallateVitamin DVitamin B 6

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsPicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Massimo Stomati, Ph. D

CONTACT

0831851303mstomati@gmail.com

Andrea Tinelli, Ph. D

CONTACT

0832394507andreatinelli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study will be a double-clind, placebp-controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Women with uterine fibroids
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 7, 2022

Study Start

July 1, 2022

Primary Completion

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 12, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)