Papilloma-induced Cervical Lesions
Conditions
Keywords
EGCG, HPV, Folic acid, Hyaluronic acid, Vitamin B12, LSIL
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.
Interventions
Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg
Sponsors
Centro di Ricerca Clinica Salentino
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positivity to HPV infection | 3 and 6 months | The outcome consists of the number of negative DNA-test obtained in patients previously positive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed