Epigallocatechin Gallate and Other Antural Compounds in HPV Infections

NCT ID: NCT06098456

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Papilloma-induced Cervical Lesions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EGCG, FA, HA, B12

Intervention Type DRUG

Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EGCG, FA, HA, B12

Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg

Intervention Type DRUG

Other Intervention Names

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Pervistop

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centro di Ricerca Clinica Salentino

NETWORK

Sponsor Role lead

Responsible Party

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ANDREA TINELLI

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Veris delli Ponti

Scorrano, Lecce, Italy

Site Status

Countries

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Italy

Other Identifiers

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HPV-EGCG

Identifier Type: -

Identifier Source: org_study_id

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