Combination of natural supplements for treating uterine fibroids
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid
This study is testing a mix of natural supplements to see if they can reduce the size of larger uterine fibroids in women who have them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 40 Years |
| Sex | Female |
| Sponsor | Lo.Li.Pharma s.r.l Industry-sponsored |
| Locations | 2 sites (Francavilla Fontana, Apulia and 1 other locations) |
| Trial ID | NCT05448365 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a combination of natural compounds, including Epigallocatechin gallate, Vitamin D, D-chiro-inositol, and Vitamin B6, on the volume of uterine fibroids. Patients with uterine fibroids measuring 4 cm or larger will receive either the treatment or a placebo over a three-month period. The primary outcome will be the change in fibroid volume, assessed at baseline and after treatment. The study aims to provide insights into non-surgical management options for symptomatic uterine fibroids.
Who should consider this trial
Good fit: Ideal candidates are women with uterine fibroids of 4 cm or larger who are experiencing symptoms and are eligible for surgery.
Not a fit: Patients who are obese, pregnant, breastfeeding, diabetic, or have a history of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive treatment option for patients suffering from uterine fibroids.
How similar studies have performed: While there is limited data on this specific combination, similar studies exploring natural supplements for uterine fibroids have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Francavilla Fontana, Apulia and 1 other locations
- Ospedale Dario camberlingo — Francavilla Fontana, Apulia, Italy (Recruiting)
- Ospedale Veris Delli Ponti — Scorrano, Apulia, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Massimo Stomati, Ph. D
- Email: mstomati@gmail.com
- Phone: 0831851303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.