Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-40
SponsorLo.Li.Pharma s.r.l
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
eligible for surgery
symptoms like menometrorrhagia or pelvic pain
Disqualifiers
BMI>30
currently pregnant or breastfeeding
diabetic
suspect of malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
Dietary supplementThe 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
Dietary supplementMaltodextrines
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: EGCG, Vit D, DCI, Vit B6Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diameter
Greater diameter of the diagnosed uterine fibroids
Time frame
3 monthsSecondary outcomes
1
Volume
Total volume of the diagnosed uterine fibroids
Time frame
3 months2
Need for surgery
The percentage of patients that decide to avoid surgery
Time frame
3 months3
pVEGF-R
the phosphorilation of VEGF receptor
Time frame
3 months4
Marker of cellular proliferation
expression of ki67, ER, PR
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov