Epigallocatechin Gallate and Other Antural Compounds in HPV Infections
Phase 2
Completed
- Conditions
- Papilloma-induced Cervical Lesions
- Interventions
- Drug: EGCG, FA, HA, B12
- Registration Number
- NCT06098456
- Lead Sponsor
- Centro di Ricerca Clinica Salentino
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 178
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment EGCG, FA, HA, B12 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.
- Primary Outcome Measures
Name Time Method Positivity to HPV infection 3 and 6 months The outcome consists of the number of negative DNA-test obtained in patients previously positive.
- Secondary Outcome Measures
Name Time Method Occurrence of lesions 3 and 6 months The outcome consists of the number of negative PAP-tests obtained in patients previously positive.
Lesions-related symptmos 3 and 6 months The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.
Trial Locations
- Locations (1)
Ospedale Veris delli Ponti
🇮🇹Scorrano, Lecce, Italy