Epigallocatechin Gallate and Other Antural Compounds in HPV Infections (EGCGHPV)

July 12, 2024 updated by: ANDREA TINELLI, Centro di Ricerca Clinica Salentino

Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests

The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.

Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.

After three months of treatment PAP-test and HPV-DNA test will be repeated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lecce
      • Scorrano, Lecce, Italy, 73020
        • Ospedale Veris Delli Ponti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Positivity to HPV-DNA test
  • PAP-test reporting LSIL or ASCUS

Exclusion Criteria:

  • HPV-related pathologies or complicances apart from LSIL or ASCUS
  • Diagnosis of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The patients in this group undergo treatment with Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg and Folic acid 400mcg by oral route once per day.
Drug: EGCG, FA, HA, B12
Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg
Other Names:
  • Pervistop
No Intervention: Control
The patients in this group follow the routine clinical practice, namely the clinical monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positivity to HPV infection
Time Frame: 3 and 6 months
The outcome consists of the number of negative DNA-test obtained in patients previously positive.
3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of lesions
Time Frame: 3 and 6 months
The outcome consists of the number of negative PAP-tests obtained in patients previously positive.
3 and 6 months
Lesions-related symptmos
Time Frame: 3 and 6 months
The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Ricerca Clinica Salentino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-EGCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papilloma-induced Cervical Lesions

Clinical Trials on EGCG, FA, HA, B12

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe