Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis - Full Text View

Sponsored by:	Shanghai University of Traditional Chinese Medicine
Information provided by:	Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00543426

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 Tradition Chinese medicine.

The second purpose is according to the international clinical guideline and the speciality of TCM to build a standard clinical trial regulation for Tradition Chinese medicine.

Condition	Intervention	Phase
Posthepatitic Cirrhosis	Drug: Fuzheng Huayu Tablets Drug: sham Fuzheng Huayu Tablets	Phase IV

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fuzheng Huayu Tablets	Drug: Fuzheng Huayu Tablets Tablet,three times a day,four tablets one time
2: Sham Comparator sham Fuzheng Huayu Tablets	Drug: sham Fuzheng Huayu Tablets 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 Posthepatitic Cirrhosis
Male or female patients between 18~65 years old
written informed concent

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

Contacts

Contact: Lieming Xu, Ph.D

86-21-5132-8888 ext 8105

Locations

China
Shuguang Hospital	Recruiting
Shanghai, China, 20021
Contact: Yueqiu Gao, Ph.D 86-21-5132-8888 ext 63857948
Sub-Investigator: Youjun Pan

Sponsors and Collaborators

Shanghai University of Traditional Chinese Medicine

Investigators

Study Director:

Zengzeng Cai, Ph.D

Shanghai Univercity of TCM

More Information

Publications:

Zhao CQ, Wu YQ, Xu LM. [Curative effects of Fuzheng Huayu capsules on hepatic fibrosis and the functional mechanisms: a review] Zhong Xi Yi Jie He Xue Bao. 2006 Sep;4(5):467-72. Chinese.

Liu P, Hu YY, Liu C, Xu LM, Liu CH, Sun KW, Hu DC, Yin YK, Zhou XQ, Wan MB, Cai X, Zhang ZQ, Ye J, Tang BZ, He J. [Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B] Zhong Xi Yi Jie He Xue Bao. 2003 Jul;1(2):89-98, 102. Chinese.

Zhang Q, Zhang WT, Wei JJ, Wang XB, Liu P. [Combined use of factor analysis and cluster analysis in classification of traditional Chinese medical syndromes in patients with posthepatitic cirrhosis] Zhong Xi Yi Jie He Xue Bao. 2005 Jan;3(1):14-8. Chinese.

Responsible Party:	Shanghai University of Traditional Chinese Medicine ( Prof. Qing-Shan ZHENG Ph.D )
Study ID Numbers:	06DZ19728
Study First Received:	October 12, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00543426
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:

Fuzheng Huayu Tablets
Multicenter clinical study

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis
Liver Cirrhosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009