Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
March 6, 2013 updated by: Shanghai University of Traditional Chinese Medicine
The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).
The second purpose is according to the international clinical guideline and the specialty of TCM to build a standard clinical trial regulation for traditional Chinese medicine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 4
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
-
-
-
Shanghai, China, 20021
- ShuGuang 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:
- Clinical diagnosis of B Post hepatitic cirrhosis.
- Male or female patients between 18~65 years old.
- Written informed consent.
Exclusion Criteria:
- Child-Pugh C above 12, or ALT > 2×ULN, TBiL > 2×ULN, or combined with hepatic encephacopathy, Obstinate ascites, bleeding tendency, hepato-renal syndrome, or primary liver cancer.
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Deformed man by the law.
- Pregnancy or breast feeding women, or unwilling to have contraception.
- Irritability body constitution, or irritability of the Fuzheng Huayu Capsules.
- Enter other trials lately one month.
- Other cause of cirrhosis.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Fuzheng Huayu Tablets
|
Tablet,three times a day,four tablets one time
|
|
Sham Comparator: 2
sham Fuzheng Huayu Tablets
|
Tablet, three times a day, four tablets one time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
hepatic function; blood test; blood ammonia and blood sugar determination
Time Frame: six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Zengzeng Cai, Ph.D, Shanghai Univercity of TCM
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
- Zhao CQ, Wu YQ, Xu LM. [Curative effects of Fuzheng Huayu capsules on hepatic fibrosis and the functional mechanisms: a review]. Zhong Xi Yi Jie He Xue Bao. 2006 Sep;4(5):467-72. doi: 10.3736/jcim20060505. Chinese.
- Liu P, Hu YY, Liu C, Xu LM, Liu CH, Sun KW, Hu DC, Yin YK, Zhou XQ, Wan MB, Cai X, Zhang ZQ, Ye J, Tang BZ, He J. [Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B]. Zhong Xi Yi Jie He Xue Bao. 2003 Jul;1(2):89-98, 102. doi: 10.3736/jcim20030204. Chinese.
- Zhang Q, Zhang WT, Wei JJ, Wang XB, Liu P. [Combined use of factor analysis and cluster analysis in classification of traditional Chinese medical syndromes in patients with posthepatitic cirrhosis]. Zhong Xi Yi Jie He Xue Bao. 2005 Jan;3(1):14-8. doi: 10.3736/jcim20050105. Chinese.
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
September 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
October 12, 2007
First Submitted That Met QC Criteria
October 12, 2007
First Posted (Estimate)
October 15, 2007
Study Record Updates
Last Update Posted (Estimate)
March 7, 2013
Last Update Submitted That Met QC Criteria
March 6, 2013
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06DZ19728
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.