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Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

NCT00622440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-04-24

Study results available
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Summary

The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

Conditions

  • Anus Neoplasms

Interventions

DRUG

AIJP (Arnebia Indigo Jade Pearl)

Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.

DRUG

Placebo

Placebo twice daily for 48 weeks.

Sponsors & Collaborators

Principal Investigators

  • Misha R Cohen, OMD, LAc · Chicken Soup Chinese Medicine

  • Naomi Jay, PhD, FNP · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-14
Primary Completion
2012-12-12
Completion
2012-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00622440 on ClinicalTrials.gov