A New Supplement for the Immune Response to HPV Infection

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.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ellagic acid + annona muricata

Drug

pills

Primary outcomes

variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells

Time frame: 6 months

Secondary outcomes

clearance of the HPV infection

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Oct 13, 2014
Registry last updated: May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed