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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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
Maltodextrines
Ospedale Dario camberlingo
Francavilla Fontana, Apulia, Italy
RECRUITINGOspedale Veris Delli Ponti
Scorrano, Apulia, Italy
NOT_YET_RECRUITINGDiameter
Greater diameter of the diagnosed uterine fibroids
Time frame: 3 months
Volume
Total volume of the diagnosed uterine fibroids
Time frame: 3 months
Need for surgery
The percentage of patients that decide to avoid surgery
Time frame: 3 months
pVEGF-R
the phosphorilation of VEGF receptor
Time frame: 3 months
Marker of cellular proliferation
expression of ki67, ER, PR
Time frame: 3 months
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