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Clinical Trials/NCT00543426
NCT00543426CompletedPhase 4

Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

Shanghai University of Traditional Chinese Medicine1 site in 1 country200 target enrollmentStarted: September 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

1

Experimental

Fuzheng Huayu Tablets

Intervention: Fuzheng Huayu Tablets (Drug)

2

Sham Comparator

sham Fuzheng Huayu Tablets

Intervention: sham Fuzheng Huayu Tablets (placebo) (Drug)

Outcomes

Primary Outcomes

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

Time Frame: six months

Secondary Outcomes

  • hepatic function; blood test; blood ammonia and blood sugar determination(six months)

Investigators

Sponsor
Shanghai University of Traditional Chinese Medicine
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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