Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis | NCT00543426

Studies
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

NCT00543426

Sponsor

Shanghai University of Traditional Chinese Medicine

Status

Completed

Last Update Posted

Mar 7, 2013Estimated

Enrollment

200Actual

Phase

Phase 4

Conditions

Posthepatitic Cirrhosis

Interventions

Fuzheng Huayu Tablets
sham Fuzheng Huayu Tablets (placebo)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

May 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Oct 12, 2007

First Submission Date that Met QC Criteria

Oct 12, 2007

First Posted Date

Oct 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2013

Last Update Posted Date

Mar 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fuzheng Huayu Tablets	Drug: Fuzheng Huayu Tablets
2	Sham Comparator	sham Fuzheng Huayu Tablets	Drug: sham Fuzheng Huayu Tablets (placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fuzheng Huayu Tablets	Drug	Tablet,three times a day,four tablets one time	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis		six months

Secondary Outcomes

Measure	Description	Time Frame
hepatic function; blood test; blood ammonia and blood sugar determination		six months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zengzeng Cai, Ph.D	Shanghai Univercity of TCM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shuguang Hospital		Shanghai		20021	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16965738	Background	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.
15339577	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.