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Could a simple supplement shrink fibroids and prevent surgery?

NCT ID NCT05448365

Disease control Sponsor: Lo.Li.Pharma s.r.l Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a daily supplement containing vitamin D, EGCG (from green tea), D-chiro-inositol, and vitamin B6 can shrink uterine fibroids in women who are eligible for surgery. Sixty women will take either the supplement or a placebo for three months. The main goal is to see if the fibroids get smaller and if fewer women end up needing surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
combination of vitamin D, epigallocatechin gallate (EGCG), D-chiro-inositol, and vitamin B6
What this could lead to
If it works, this could offer a natural supplement option to shrink fibroids and help some women avoid surgery.
What could go wrong
This is a small early-phase trial with only 60 participants and no phase designation, so results may not be conclusive. The supplement may not shrink fibroids enough to make a real difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

leiomyoma uterine corpus leiomyoma vitamin D deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

D-chiro-inositol Epigallocatechin gallate Inositol Uterine fibroids Vitamin B6 Vitamin D

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ospedale Dario camberlingo

    RECRUITING

    Francavilla Fontana, Apulia, 72021, Italy

  • Ospedale Veris Delli Ponti

    NOT_YET_RECRUITING

    Scorrano, Apulia, 73020, Italy

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