Shuguang Hospital
Shanghai, 20021, China
Completed
NCT Number: NCT00543426
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Fuzheng Huayu Tablets
DrugTablet,three times a day,four tablets one time
sham Fuzheng Huayu Tablets (placebo)
DrugTablet, three times a day, four tablets one time
Primary outcomes
-
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
Time frame: six months
Secondary outcomes
-
hepatic function; blood test; blood ammonia and blood sugar determination
Time frame: six months
Sponsors and collaborators
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Other
Registry information
Important dates
- Study start
- 2007
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Oct 15, 2007
- Registry last updated
- Mar 7, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.