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NCT01338714 Clinical Trial

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

Liver Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01338714
Other study ID # 100001-62-010
Secondary ID 100-00-62-01
Status Completed
Phase Phase 3
First received April 18, 2011
Last updated May 6, 2014
Start date May 2011
Est. completion date September 2012

Study information
Verified date May 2014
Source Taipei City Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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

Description:

% change HBV DNA title and liver function.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date September 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Compound Herbal Formula (RHD-1)
100 ml/per day
• dilute RHD-1
100 ml/per day

Locations
Country Name City State
Taiwan Taipei City Hospital Taipei

Sponsors (2)
Lead Sponsor Collaborator
Taipei City Hospital National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chu CJ, Hussain M, Lok AS. Quantitative serum HBV DNA levels during different stages of chronic hepatitis B infection. Hepatology. 2002 Dec;36(6):1408-15. — View Citation

Hsu CH, Hwang KC, Chiang YH, Chou P. The mushroom Agaricus blazei Murill extract normalizes liver function in patients with chronic hepatitis B. J Altern Complement Med. 2008 Apr;14(3):299-301. doi: 10.1089/acm.2006.6344. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary the % change of HBV DNA title 6 weeks Yes
Secondary the % change of GPT 6 weeks Yes
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