D-chiro-inositol, Epigallocatechin Gallate, Inositol, Uterine Fibroids, Vitamin B6, Vitamin D
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTEpigallocatechin 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
DIETARY_SUPPLEMENTPlacebo
Maltodextrines
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study will be a double-clind, placebp-controlled trial
Intervention model description
Women with uterine fibroids
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diameter | 3 months | Greater diameter of the diagnosed uterine fibroids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume | 3 months | Total volume of the diagnosed uterine fibroids |
| Need for surgery | 3 months | The percentage of patients that decide to avoid surgery |
| pVEGF-R | 3 months | the phosphorilation of VEGF receptor |
| Marker of cellular proliferation | 3 months | expression of ki67, ER, PR |
Countries
Italy
Contacts
CONTACTMassimo Stomati, Ph. D
CONTACTAndrea Tinelli, Ph. D
Outcome results
None listed