Back to resultsA New Supplement for the Immune Response to HPV Infection
Primary Purpose
HPV Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ellagic acid + annona muricata
Sponsored by
About this trial
This is an interventional treatment trial for HPV Infection focused on measuring HPV, L-SIL
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
supplement
not intervention
Arm Description
Outcomes
Primary Outcome Measures
variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells
Secondary Outcome Measures
clearance of the HPV infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02263378
Brief Title
A New Supplement for the Immune Response to HPV Infection
Official Title
Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection
Keywords
HPV, L-SIL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supplement
Arm Type
Experimental
Arm Title
not intervention
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ellagic acid + annona muricata
Intervention Description
pills
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
clearance of the HPV infection
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
A New Supplement for the Immune Response to HPV Infection
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