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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01708733
First received: October 15, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 Taipei City Hospital:

Primary Outcome Measures:
  • HCV RNA titer [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum GPT level [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • WHOQOL-BREF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708733

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

No publications provided

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
Study First Received: October 15, 2012
Last Updated: October 15, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei City Hospital:
HCV carrier
Chinese herbal medicine
Liver function
HCV RNA titer

ClinicalTrials.gov processed this record on April 15, 2014