NCT02263378

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

July 17, 2014

Last Update Submit

May 23, 2016

Conditions

HPV Infection

Keywords

HPV, L-SIL

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • clearance of the HPV infection

    6 months

Study Arms (2)

supplement

EXPERIMENTAL
Drug: ellagic acid + annona muricata

not intervention

PLACEBO COMPARATOR
Drug: ellagic acid + annona muricata

Interventions

ellagic acid + annona muricataDRUG

pills

not interventionsupplement

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with high risk HPV infection
  • histological diagnosis of L-SIL

You may not qualify if:

  • women with no high risk HPV infection
  • women without histological diagnosis of L-SIL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Ellagic Acid

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 17, 2014

First Posted

October 13, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05