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Phase II Evaluation of AHCC for the Eradication of HPV Infections

NCT02405533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-20

No results posted yet for this study

Summary

This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication persistent high risk HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment compared to placebo.

Conditions

Interventions

DIETARY_SUPPLEMENT

AHCC 3 grams once a day

AHCC supplementation x 6 months with Placebo x 6 months

OTHER

Placebo

Placebo supplementation x 12 months

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Judith A Smith, Pharm.D. · UTTexas_Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405533 on ClinicalTrials.gov