Posthepatitic Cirrhosis
Conditions
Keywords
Fuzheng Huayu Tablets, Multicenter clinical study
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.
Interventions
Tablet,three times a day,four tablets one time
DRUGsham Fuzheng Huayu Tablets (placebo)
Tablet, three times a day, four tablets one time
Sponsors
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis | six months |
Secondary
| Measure | Time frame |
|---|---|
| hepatic function; blood test; blood ammonia and blood sugar determination | six months |
Countries
China
Outcome results
None listed