Back to resultsThe Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function
Primary Purpose
Liver Dysfunction
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Compound Herbal Formula (RHD-1)
dilute RHD-1
Sponsored by
About this trial
This is an interventional treatment trial for Liver Dysfunction focused on measuring HBV carrier, HBV DNA title, Chinese Medicine, Liver function, RHD-1
Eligibility Criteria
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.
Sites / Locations
- Taipei City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A foumula
B formula
Arm Description
Compound Herbal Formula (RHD-1)
dilute Compound Herbal Formula
Outcomes
Primary Outcome Measures
the % change of HBV DNA title
Secondary Outcome Measures
the % change of GPT
Full Information
NCT ID
NCT01338714
First Posted
April 18, 2011
Last Updated
May 6, 2014
Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT01338714
Brief Title
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function
Official Title
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
% change HBV DNA title and liver function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction
Keywords
HBV carrier, HBV DNA title, Chinese Medicine, Liver function, RHD-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A foumula
Arm Type
Experimental
Arm Description
Compound Herbal Formula (RHD-1)
Arm Title
B formula
Arm Type
Placebo Comparator
Arm Description
dilute Compound Herbal Formula
Intervention Type
Other
Intervention Name(s)
Compound Herbal Formula (RHD-1)
Other Intervention Name(s)
Chinese herbal medicine
Intervention Description
100 ml/per day
Intervention Type
Other
Intervention Name(s)
dilute RHD-1
Other Intervention Name(s)
Chinese herbal medicine dilute
Intervention Description
100 ml/per day
Primary Outcome Measure Information:
Title
the % change of HBV DNA title
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
the % change of GPT
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18370584
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.
Results Reference
background
PubMed Identifier
12447866
Citation
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. doi: 10.1053/jhep.2002.36949.
Results Reference
background
PubMed Identifier
23863086
Citation
Lee CJ, Cheng CH, Li YH, Liu CY, Hsu CH. A Chinese medicine, Kuan-Sin-Yin decoction, improves liver function in hepatitis B virus carriers: a randomized, controlled study. J Altern Complement Med. 2013 Dec;19(12):964-9. doi: 10.1089/acm.2013.0136. Epub 2013 Jul 17.
Results Reference
derived
Learn more about this trial
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function
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