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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708733
First Posted: October 17, 2012
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
  Purpose
The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.

Condition Intervention Phase
Liver Function Drug: KSY Phase 2 Phase 3

Study Type: Interventional
Study Design: 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.

Further study details as provided by Chung-Hua Hsu, Taipei City Hospital:

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

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

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

Enrollment: 57
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

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 Submitted: October 15, 2012
First Posted: October 17, 2012
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