EGCGHPV: Epigallocatechin Gallate and Other Antural Compounds in HPV Infections

• Sponsor: Centro di Ricerca Clinica Salentino (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06098456
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.4
• Patients Per Site Per Month: 11.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Papilloma-induced Cervical Lesions	Drug: EGCG, FA, HA, B12	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 15, 2024

Arms and Interventions

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
No Intervention: Control The patients in this group follow the routine clinical practice, namely the clinical monitoring.

Outcome Measures

Primary Outcome Measures

1. Positivity to HPV infection [3 months]

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

Secondary Outcome Measures

1. Occurrence of lesions [3 months]

   The outcome consists of the number of negative PAP-tests obtained in patients previously positive.

2. Lesions-related symptmos [3 months]

   The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Veris delli Ponti	Scorrano	Lecce	Italy	73020

Sponsors and Collaborators

• Centro di Ricerca Clinica Salentino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ANDREA TINELLI, Professor, Centro di Ricerca Clinica Salentino
• ClinicalTrials.gov Identifier: NCT06098456
• Other Study ID Numbers: HPV-EGCG
• First Posted: Oct 24, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• 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
• Keywords provided by ANDREA TINELLI, Professor, Centro di Ricerca Clinica Salentino: EGCG; HPV; Folic acid; Hyaluronic acid; Vitamin B12; LSIL
• Additional relevant MeSH terms: Papilloma

Study Results

No Results Posted as of Oct 25, 2023