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Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

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ClinicalTrials.gov Identifier: NCT00543426
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

October 12, 2007
October 15, 2007
March 7, 2013
September 2007
May 2009   (Final data collection date for primary outcome measure)
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis [ Time Frame: six months ]
Same as current
Complete list of historical versions of study NCT00543426 on ClinicalTrials.gov Archive Site
hepatic function; blood test; blood ammonia and blood sugar determination [ Time Frame: six months ]
Same as current
Not Provided
Not Provided
 
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posthepatitic Cirrhosis
  • Drug: Fuzheng Huayu Tablets
    Tablet,three times a day,four tablets one time
  • Drug: sham Fuzheng Huayu Tablets (placebo)
    Tablet, three times a day, four tablets one time
  • Experimental: 1
    Fuzheng Huayu Tablets
    Intervention: Drug: Fuzheng Huayu Tablets
  • Sham Comparator: 2
    sham Fuzheng Huayu Tablets
    Intervention: Drug: sham Fuzheng Huayu Tablets (placebo)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Same as current
June 2009
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00543426
06DZ19728
Yes
Not Provided
Not Provided
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Not Provided
Study Director: Zengzeng Cai, Ph.D Shanghai Univercity of TCM
Shanghai University of Traditional Chinese Medicine
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP