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
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
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
NCT ID
NCT06098456
First Posted
October 19, 2023
Last Updated
October 24, 2023
Sponsor
Centro di Ricerca Clinica Salentino
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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