A New Supplement for the Immune Response to HPV Infection
Not Applicable
Completed
- Conditions
- HPV Infection
- Interventions
- Drug: ellagic acid + annona muricata
- Registration Number
- NCT02263378
- Lead Sponsor
- University of Messina
- Brief Summary
The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- women with high risk HPV infection
- histological diagnosis of L-SIL
Exclusion Criteria
- women with no high risk HPV infection
- women without histological diagnosis of L-SIL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description supplement ellagic acid + annona muricata - not intervention ellagic acid + annona muricata -
- Primary Outcome Measures
Name Time Method variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells 6 months
- Secondary Outcome Measures
Name Time Method clearance of the HPV infection 6 months