NCT01708733CompletedPhase 2
An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Taipei City Hospital
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- HCV RNA titer
Study Overview
Brief Summary
The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.
Detailed Description
percentage of change on HCV RNA titer and liver function (GPT).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •40 < GPT <200 HCV carrier Age: 18-65 yrs old
Exclusion Criteria
- •Creatinine >2.0 mg/dL Total bilirubin > 2.0mg/dL Not suitable patients diagnosis by physician in charge.
Arms & Interventions
KSY
Experimental
KSY, 100mg decoction by mouth per day for 6 weeks
Intervention: KSY (Drug)
Outcomes
Primary Outcomes
HCV RNA titer
Time Frame: 6 weeks
Secondary Outcomes
- Serum GPT level(6 weeks)
Investigators
Chung-Hua Hsu
chief medical officer
Taipei City Hospital
Study Sites (1)
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