The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection.

March 15, 2024 updated by: Lo.Li.Pharma s.r.l

A Pilot Study to Test the Effect of the Association of Epigallocatechin Gallate (EGCG), Folic Acid and Vitamin B12 in Preventing the Persistence of Human Papilloma Virus (HPV) Infection.

The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Modena, Italy, 41124
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Modena
        • Contact:
          • Giovanni Grandi

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HR-HPV DNA test positivity

Exclusion Criteria:

  • No HSIL

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Dietary supplement: EGCG + folic acid + B12
EGCG + folic acid + B12
No Intervention: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV DNA test negativity
Time Frame: 8 months of treatment
Percentage
8 months of treatment

Collaborators and Investigators

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

Sponsor

Lo.Li.Pharma s.r.l

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)

February 19, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPISTOP_22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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