Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | No Intervention | The patients in this group follow the routine clinical practice, namely the clinical monitoring. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGCG, FA, HA, B12 | Drug | Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positivity to HPV infection | The outcome consists of the number of negative DNA-test obtained in patients previously positive. | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of lesions | The outcome consists of the number of negative PAP-tests obtained in patients previously positive. | 3 and 6 months |
| Lesions-related symptmos | The ouctome includes the occurrence of bleeding, flogosis, or sexual pain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Veris delli Ponti | Scorrano | Lecce | 73020 | Italy |
Not provided
| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
Not provided
Not provided
Not provided
Not provided
| 3 and 6 months |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |