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Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female

NCT04633330 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-05

No results posted yet for this study

Summary

This is a multi-centre, randomised, double blind, placebo-controlled study on female participants with diagnosis of high-risk human papillomavirus (HR-HPV) infection to evaluate the clearance capacity of AHCC®.

Conditions

  • High Risk Human Papillomavirus Infection
  • Low Grade Squamous Intraepithelial Lesion

Interventions

DRUG

AHCC®capsules

AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.

DRUG

Simulation of AHCC®capsules

TID for 6 months after enrolment. A compensation of AHCC®is provided to participant from control arm when HR-HPV positive at 6 months after enrolment.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT04633330 on ClinicalTrials.gov