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

Centro di Ricerca Clinica Salentino

Status and phase: Completed; Phase 2

Conditions: Papilloma-induced Cervical Lesions

Treatments: Drug: EGCG, FA, HA, B12

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06098456

HPV-EGCG

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

178 participants in 2 patient groups

Treatment

Experimental group

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.

Treatment:

Drug: EGCG, FA, HA, B12

Control

No Intervention group

Description:

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