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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

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT02263378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
clearance of the HPV infection [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
clearance of the HPV infection [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Supplement for the Immune Response to HPV Infection
Official Title  ICMJE Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HPV Infection
Intervention  ICMJE Drug: ellagic acid + annona muricata
pills
Study Arms  ICMJE
  • Experimental: supplement
    Intervention: Drug: ellagic acid + annona muricata
  • Placebo Comparator: not intervention
    Intervention: Drug: ellagic acid + annona muricata
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2014)
100
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02263378
Other Study ID Numbers  ICMJE OASIT-K
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rosario D'anna, University of Messina
Study Sponsor  ICMJE University of Messina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Messina
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP