Posthepatitic Cirrhosis Clinical Trial
Official title:
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | June 2009 |
| Est. primary completion date | May 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Shuguang Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai University of Traditional Chinese Medicine |
China,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis | six months | Yes | |
| Secondary | hepatic function; blood test; blood ammonia and blood sugar determination | six months | Yes |