Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

Not Applicable

Completed

• Conditions: Cervix Lesion; Papilloma
• Interventions: Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

• Registration Number: NCT05625308
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-11
• Primary Completion: 2022-11-09
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-22
• Study Completion: 2022-12-02
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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
• Cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Co-treatment with EGCG, FA, B12, and HA	Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid	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.

Primary Outcome Measures

Name	Time	Method
Regression of cervical lesions	12 weeks	The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.

Trial Locations

Locations (1)

Clinica Alma Res; 🇮🇹 Roma, Italy