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

NCT ID: NCT05448365

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women with uterine fibroids
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The study will be a double-clind, placebp-controlled trial

Study Groups

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EGCG, Vit D, DCI, Vit B6

Women with uterine fibroids randomized to treatment group

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Women with uterine fibroids randomized to placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrines

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrines

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale Dario camberlingo

Francavilla Fontana, Apulia, Italy

Site Status RECRUITING

Ospedale Veris Delli Ponti

Scorrano, Apulia, Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Massimo Stomati, Ph. D

Role: CONTACT

0831851303

Andrea Tinelli, Ph. D

Role: CONTACT

0832394507

Facility Contacts

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Massimo Stomati, Ph.D

Role: primary

Andrea Tinelli, Ph. D

Role: primary

Other Identifiers

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DELPHYS PLUS

Identifier Type: -

Identifier Source: org_study_id

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