A New Supplement for the Immune Response to HPV Infection

University of Messina

Status: Completed

Conditions: HPV Infection

Treatments: Drug: ellagic acid + annona muricata

Study type: Interventional

Funder types: Other

Identifiers

NCT02263378

OASIT-K

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

supplement

Experimental group

Treatment:

Drug: ellagic acid + annona muricata

not intervention

Placebo Comparator group

Treatment:

Drug: ellagic acid + annona muricata