The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function

May 6, 2014 updated by: Chung-Hua Hsu, Taipei City Hospital

The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function: a Randomized Controlled Trial

The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective on HBV Carrier With Abnormal Liver Function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

% change HBV DNA title and liver function.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 886
        • Taipei City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 < GPT <200 HBV carrier Age: 18-65 yrs old

Exclusion:

Creatinine >2.0 mg/dL Total bilirubin > 2.0mg/dL Not suitable patients diagnosis by physician in charge.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A foumula
Compound Herbal Formula (RHD-1)
Other: Compound Herbal Formula (RHD-1)
100 ml/per day
Other Names:
  • Chinese herbal medicine
Placebo Comparator: B formula
dilute Compound Herbal Formula
Other: dilute RHD-1
100 ml/per day
Other Names:
  • Chinese herbal medicine dilute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the % change of HBV DNA title
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the % change of GPT
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Collaborators

National Yang Ming University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100001-62-010
  • 100-00-62-01 (Other Grant/Funding Number: 100-00-62-01A)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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