Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

NCT ID: NCT00543426

Last Updated: 2013-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Posthepatitic Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Fuzheng Huayu Tablets

Group Type EXPERIMENTAL

Fuzheng Huayu Tablets

Intervention Type DRUG

Tablet,three times a day,four tablets one time

2

sham Fuzheng Huayu Tablets

Group Type SHAM_COMPARATOR

sham Fuzheng Huayu Tablets (placebo)

Intervention Type DRUG

Tablet, three times a day, four tablets one time

Interventions

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Fuzheng Huayu Tablets

Tablet,three times a day,four tablets one time

Intervention Type DRUG

sham Fuzheng Huayu Tablets (placebo)

Tablet, three times a day, four tablets one time

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zengzeng Cai, Ph.D

Role: STUDY_DIRECTOR

Shanghai Univercity of TCM

Locations

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Shuguang Hospital

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 16965738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15339577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15644152 (View on PubMed)

Other Identifiers

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06DZ19728

Identifier Type: -

Identifier Source: org_study_id

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