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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014