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Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

Primary Purpose

Posthepatitic Cirrhosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fuzheng Huayu Tablets
sham Fuzheng Huayu Tablets (placebo)
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posthepatitic Cirrhosis focused on measuring Fuzheng Huayu Tablets, Multicenter clinical study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shuguang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Fuzheng Huayu Tablets

sham Fuzheng Huayu Tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2007
Last Updated
March 6, 2013
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00543426
Brief Title
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Official Title
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posthepatitic Cirrhosis
Keywords
Fuzheng Huayu Tablets, Multicenter clinical study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fuzheng Huayu Tablets
Arm Title
2
Arm Type
Sham Comparator
Arm Description
sham Fuzheng Huayu Tablets
Intervention Type
Drug
Intervention Name(s)
Fuzheng Huayu Tablets
Intervention Description
Tablet,three times a day,four tablets one time
Intervention Type
Drug
Intervention Name(s)
sham Fuzheng Huayu Tablets (placebo)
Intervention Description
Tablet, three times a day, four tablets one time
Primary Outcome Measure Information:
Title
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
Time Frame
six months
Secondary Outcome Measure Information:
Title
hepatic function; blood test; blood ammonia and blood sugar determination
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zengzeng Cai, Ph.D
Organizational Affiliation
Shanghai Univercity of TCM
Official's Role
Study Director
Facility Information:
Facility Name
Shuguang Hospital
City
Shanghai
ZIP/Postal Code
20021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16965738
Citation
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.
Results Reference
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PubMed Identifier
15339577
Citation
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.
Results Reference
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PubMed Identifier
15644152
Citation
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.
Results Reference
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Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

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