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OpenTrials
Completed

NCT Number: NCT06098456

Epigallocatechin Gallate and Other Antural Compounds in HPV Infections

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.

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Key information

Conditions

Papilloma-induced Cervical Lesions

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Veris delli Ponti

Scorrano, Lecce, 73020, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGCG, FA, HA, B12

Drug

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

Other names: Pervistop

Primary outcomes

  1. Positivity to HPV infection

    Time frame: 3 and 6 months

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

Secondary outcomes

  1. Occurrence of lesions

    Time frame: 3 and 6 months

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

  2. Lesions-related symptmos

    Time frame: 3 and 6 months

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

Sponsors and collaborators

Lead sponsor

Centro di Ricerca Clinica Salentino

Network

Registry information

Official study title

Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests

Acronym: EGCGHPV

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.