The Effect of Chinese Herbal Formula (KSY) on HCV Carrier... | NCT01708733

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

NCT01708733

Sponsor

Taipei City Hospital

Status

Completed

Last Update Posted

May 29, 2014Estimated

Enrollment

57Actual

Phase

Phase 2Phase 3

Conditions

Liver Function

Interventions

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2014

Last Update Posted Date

May 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KSY diluted	Placebo Comparator	KSY diluted, 100mg decoction by mouth per day for 6 weeks
KSY	Experimental	KSY, 100mg decoction by mouth per day for 6 weeks	Drug: KSY

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KSY	Drug	Chinese herbal formula	KSY

Measure	Description	Time Frame
HCV RNA titer		6 weeks

Measure	Description	Time Frame
Serum GPT level		6 weeks

Measure	Description	Time Frame
WHOQOL-BREF		6 weeks

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei City Hospital		Taipei	Taiwan	886	Taiwan