A New Supplement for the Immune Response to HPV Infection

NCT ID: NCT02263378

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

HPV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

supplement

Group Type: EXPERIMENTAL

ellagic acid + annona muricata

Intervention Type: DRUG

pills

not intervention

Group Type: PLACEBO_COMPARATOR

ellagic acid + annona muricata

Intervention Type: DRUG

pills

Interventions

ellagic acid + annona muricata

pills

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Rosario D'anna

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OASIT-K

Identifier Type: -

Identifier Source: org_study_id