Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

NCT00543426 | Completed Phase 4 DMC

• 1 other identifier: 06DZ19728
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Posthepatitic Cirrhosis

Keywords

Fuzheng Huayu Tablets; Multicenter clinical study

Outcome Measures

Primary Outcomes (1)

• the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis

  six months

Secondary Outcomes (1)

• hepatic function; blood test; blood ammonia and blood sugar determination

  six months

Study Arms (2)

1

EXPERIMENTAL

Fuzheng Huayu Tablets

Drug: Fuzheng Huayu Tablets

2

SHAM COMPARATOR

sham Fuzheng Huayu Tablets

Drug: sham Fuzheng Huayu Tablets (placebo)

Interventions

Fuzheng Huayu Tablets DRUG

Tablet,three times a day,four tablets one time

1

sham Fuzheng Huayu Tablets (placebo) DRUG

Tablet, three times a day, four tablets one time

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of B Post hepatitic cirrhosis.
• Male or female patients between 18\~65 years old.
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Shuguang Hospital

Shanghai, 20021, China

Location

Related Publications (3)

• 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. doi: 10.3736/jcim20060505. Chinese.

  PMID: 16965738 BACKGROUND

• 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. doi: 10.3736/jcim20030204. Chinese.

  PMID: 15339577 BACKGROUND

• 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. doi: 10.3736/jcim20050105. Chinese.

  PMID: 15644152 BACKGROUND

MeSH Terms

Interventions

fuzheng huayu

Study Officials

• Zengzeng Cai, Ph.D

  Shanghai Univercity of TCM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2007
• First Posted: October 15, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 7, 2013

Record last verified: 2009-06

Locations

CN (1)