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The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function

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ClinicalTrials.gov Identifier: NCT01708733
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Function Drug: KSY Phase 2 Phase 3

Detailed Description:
percentage of change on HCV RNA titer and liver function (GPT).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.
Study Start Date : August 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Placebo Comparator: KSY diluted
KSY diluted, 100mg decoction by mouth per day for 6 weeks
Experimental: KSY
KSY, 100mg decoction by mouth per day for 6 weeks
Drug: KSY
Chinese herbal formula



Primary Outcome Measures :
  1. HCV RNA titer [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Serum GPT level [ Time Frame: 6 weeks ]

Other Outcome Measures:
  1. WHOQOL-BREF [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708733


Locations
Taiwan
Taipei City Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Taipei City Hospital

Responsible Party: Chung-Hua Hsu, chief medical officer, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT01708733     History of Changes
Other Study ID Numbers: 101001-62-010
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Chung-Hua Hsu, Taipei City Hospital:
HCV carrier
Chinese herbal medicine
Liver function
HCV RNA titer