NCT01708733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

October 15, 2012

Last Update Submit

May 28, 2014

Conditions

Liver Function

Keywords

HCV carrierChinese herbal medicineLiver functionHCV RNA titer

Outcome Measures

Primary Outcomes (1)

  • HCV RNA titer

    6 weeks

Secondary Outcomes (1)

  • Serum GPT level

    6 weeks

Other Outcomes (1)

  • WHOQOL-BREF

    6 weeks

Study Arms (2)

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

KSYDRUG

Chinese herbal formula

KSY

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< GPT \<200 HCV carrier Age: 18-65 yrs old

You may not qualify if:

  • Creatinine \>2.0 mg/dL Total bilirubin \> 2.0mg/dL Not suitable patients diagnosis by physician in charge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan, 886, Taiwan

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief medical officer

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 17, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

TW(1)