Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lo.Li.Pharma s.r.l
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Regression of cervical lesions
Study Overview
Brief Summary
To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HPV infections
- •Occurrence of low-grade cervical lesions
Exclusion Criteria
- •Diagnosis of malignancy or severe cervical lesions
- •Concurrent uterine pathologies
- •Pregnancy or intended to seek pregnancy in the next three months
Arms & Interventions
Co-treatment with EGCG, FA, B12, and HA
One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks.
Intervention: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid (Dietary Supplement)
Control
Untreated women.
Outcomes
Primary Outcomes
Regression of cervical lesions
Time Frame: 12 weeks
The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.
Secondary Outcomes
No secondary outcomes reported