Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Fuzheng Huayu Tablets |
Drug: Fuzheng Huayu Tablets
Tablet,three times a day,four tablets one time
|
| Sham Comparator: 2 sham Fuzheng Huayu Tablets |
Drug: sham Fuzheng Huayu Tablets (placebo)
Tablet, three times a day, four tablets one time
|
Outcome Measures
Primary Outcome Measures
- the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis [six months]
Secondary Outcome Measures
- hepatic function; blood test; blood ammonia and blood sugar determination [six months]
Eligibility Criteria
Criteria
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.
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Deformed man by the law.
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Pregnancy or breast feeding women, or unwilling to have contraception.
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Irritability body constitution, or irritability of the Fuzheng Huayu Capsules.
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Enter other trials lately one month.
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Other cause of cirrhosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shuguang Hospital | Shanghai | China | 20021 |
Sponsors and Collaborators
- Shanghai University of Traditional Chinese Medicine
Investigators
- Study Director: Zengzeng Cai, Ph.D, Shanghai Univercity of TCM
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. 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. Chinese.
- 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. Review. Chinese.
- 06DZ19728