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

Liver Function Clinical Trial

Official title:

An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708733
• Other study ID #: 101001-62-010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 15, 2012
• Last updated: May 28, 2014
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Function

Intervention

Drug:
• KSY
Chinese herbal formula

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WHOQOL-BREF		6 weeks	No
Primary	HCV RNA titer		6 weeks	Yes
Secondary	Serum GPT level		6 weeks	Yes