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Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00543426
First received: October 12, 2007
Last updated: March 6, 2013
Last verified: June 2009
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hepatic function; blood test; blood ammonia and blood sugar determination [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00543426     History of Changes
Other Study ID Numbers: 06DZ19728
Study First Received: October 12, 2007
Last Updated: March 6, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Fuzheng Huayu Tablets
Multicenter clinical study

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013