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

Primary Purpose

Papilloma-induced Cervical Lesions

Status
Enrolling by invitation
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
EGCG, FA, HA, B12
Sponsored by
Centro di Ricerca Clinica Salentino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papilloma-induced Cervical Lesions focused on measuring EGCG, HPV, Folic acid, Hyaluronic acid, Vitamin B12, LSIL

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Veris delli Ponti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

The patients in this group follow the routine clinical practice, namely the clinical monitoring.

Outcomes

Primary Outcome Measures

Positivity to HPV infection
The outcome consists of the number of negative DNA-test obtained in patients previously positive.

Secondary Outcome Measures

Occurrence of lesions
The outcome consists of the number of negative PAP-tests obtained in patients previously positive.
Lesions-related symptmos
The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.

Full Information

First Posted
October 19, 2023
Last Updated
October 24, 2023
Sponsor
Centro di Ricerca Clinica Salentino
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1. Study Identification

Unique Protocol Identification Number
NCT06098456
Brief Title
Epigallocatechin Gallate and Other Antural Compounds in HPV Infections
Acronym
EGCGHPV
Official Title
Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro di Ricerca Clinica Salentino

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papilloma-induced Cervical Lesions
Keywords
EGCG, HPV, Folic acid, Hyaluronic acid, Vitamin B12, LSIL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients in this group follow the routine clinical practice, namely the clinical monitoring.
Intervention Type
Drug
Intervention Name(s)
EGCG, FA, HA, B12
Intervention Description
Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg
Primary Outcome Measure Information:
Title
Positivity to HPV infection
Description
The outcome consists of the number of negative DNA-test obtained in patients previously positive.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Occurrence of lesions
Description
The outcome consists of the number of negative PAP-tests obtained in patients previously positive.
Time Frame
3 months
Title
Lesions-related symptmos
Description
The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ospedale Veris delli Ponti
City
Scorrano
State/Province
Lecce
ZIP/Postal Code
73020
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Epigallocatechin Gallate and Other Antural Compounds in HPV Infections

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