Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
NCT ID: NCT05448365
Last Updated: 2025-08-12
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-07-01
2026-01-01
Brief Summary
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The patients will be evaluated at baseline and after three months of treatment with placebo or product.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EGCG, Vit D, DCI, Vit B6
Women with uterine fibroids randomized to treatment group
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
Placebo
Women with uterine fibroids randomized to placebo group
Placebo
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
Placebo
Maltodextrines
Eligibility Criteria
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Inclusion Criteria
2. eligible for surgery
3. symptoms like menometrorrhagia or pelvic pain
Exclusion Criteria
2. currently pregnant or breastfeeding
3. diabetic
4. suspect of malignancy
5. diagnosis of cancer
30 Years
40 Years
FEMALE
No
Sponsors
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Lo.Li.Pharma s.r.l
INDUSTRY
Responsible Party
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Locations
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Ospedale Dario camberlingo
Francavilla Fontana, Apulia, Italy
Ospedale Veris Delli Ponti
Scorrano, Apulia, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DELPHYS PLUS
Identifier Type: -
Identifier Source: org_study_id
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