Study Results
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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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2007-09-30
2009-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Fuzheng Huayu Tablets
Fuzheng Huayu Tablets
Tablet,three times a day,four tablets one time
2
sham Fuzheng Huayu Tablets
sham Fuzheng Huayu Tablets (placebo)
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
sham Fuzheng Huayu Tablets (placebo)
Tablet, three times a day, four tablets one time
Eligibility Criteria
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Inclusion Criteria
* Male or female patients between 18\~65 years old.
* Written informed consent.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
Other Identifiers
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06DZ19728
Identifier Type: -
Identifier Source: org_study_id
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