A New Supplement for the Immune Response to HPV Infection

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263378
• Other study ID #: OASIT-K
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: May 23, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Minister of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HPV Infection
• Infection

Intervention

Drug:
• ellagic acid + annona muricata
pills

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells		6 months	No
Secondary	clearance of the HPV infection		6 months	No