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

• Sponsor: Taipei City Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01338714
• Collaborator: National Yang Ming University (Other)
• Enrollment: 58
• Location: 1
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction	Other: Compound Herbal Formula (RHD-1); Other: dilute RHD-1	Phase 3

Detailed Description

% change HBV DNA title and liver function.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function: a Randomized Controlled Trial
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the % change of HBV DNA title [6 weeks]

Secondary Outcome Measures

1. the % change of GPT [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei City Hospital	Taipei		Taiwan	886

Sponsors and Collaborators

• Taipei City Hospital
• National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Chung-Hua Hsu, vice president, Taipei City Hospital
• ClinicalTrials.gov Identifier: NCT01338714
• Other Study ID Numbers: 100001-62-010; 100-00-62-01
• First Posted: Apr 19, 2011
• Last Update Posted: May 7, 2014
• Last Verified: May 1, 2014

• Keywords provided by Chung-Hua Hsu, vice president, Taipei City Hospital: HBV carrier; HBV DNA title; Chinese Medicine; Liver function; RHD-1
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of May 7, 2014