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

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 Overview

• Status: Completed
• Conditions: Papilloma; Cervix Lesion
• Intervention / Treatment: Dietary supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00198
    • Clinica Alma Res

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.
No Intervention: Control; Untreated women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regression of cervical lesions	The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.	12 weeks

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l
• Investigators: Principal Investigator: Cesare Aragona, MD, Clinica Alma Res

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Neuroprotective Agents; Protective Agents; Micronutrients; Adjuvants, Immunologic; Vitamins; Antioxidants; Vitamin B Complex; Hematinics; Anticarcinogenic Agents; Viscosupplements; Antimutagenic Agents; Folic Acid; Vitamin B 12; Hydroxocobalamin; Hyaluronic Acid; Epigallocatechin gallate
• Other Study ID Numbers: HPV-NAT-COM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No