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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

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
Posthepatitic Cirrhosis Drug: Fuzheng Huayu Tablets Drug: sham Fuzheng Huayu Tablets (placebo) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Study Start Date : September 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis [ Time Frame: six months ]

Secondary Outcome Measures :
  1. hepatic function; blood test; blood ammonia and blood sugar determination [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543426


Locations
China
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