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A New Supplement for the Immune Response to HPV Infection

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ClinicalTrials.gov Identifier: NCT02263378
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Rosario D'anna, 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.

Condition or disease Intervention/treatment Phase
HPV Infection Drug: ellagic acid + annona muricata Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.
Study Start Date : September 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: supplement Drug: ellagic acid + annona muricata
pills

Placebo Comparator: not intervention Drug: ellagic acid + annona muricata
pills




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. clearance of the HPV infection [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov Identifier: NCT02263378     History of Changes
Other Study ID Numbers: OASIT-K
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by Rosario D'anna, University of Messina:
HPV, L-SIL
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections