<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01708733</url>
  </required_header>
  <id_info>
    <org_study_id>101001-62-010</org_study_id>
    <nct_id>NCT01708733</nct_id>
  </id_info>
  <brief_title>The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function</brief_title>
  <official_title>An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei City Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei City Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on&#xD;
      HCV Carrier With Abnormal Liver Function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      percentage of change on HCV RNA titer and liver function (GPT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HCV RNA titer</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum GPT level</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>WHOQOL-BREF</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Liver Function</condition>
  <arm_group>
    <arm_group_label>KSY diluted</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>KSY diluted, 100mg decoction by mouth per day for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KSY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KSY, 100mg decoction by mouth per day for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KSY</intervention_name>
    <description>Chinese herbal formula</description>
    <arm_group_label>KSY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 &lt; GPT &lt;200 HCV carrier Age: 18-65 yrs old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Creatinine &gt;2.0 mg/dL Total bilirubin &gt; 2.0mg/dL Not suitable patients diagnosis by&#xD;
             physician in charge.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taipei City Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>May 28, 2014</last_update_submitted>
  <last_update_submitted_qc>May 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei City Hospital</investigator_affiliation>
    <investigator_full_name>Chung-Hua Hsu</investigator_full_name>
    <investigator_title>chief medical officer</investigator_title>
  </responsible_party>
  <keyword>HCV carrier</keyword>
  <keyword>Chinese herbal medicine</keyword>
  <keyword>Liver function</keyword>
  <keyword>HCV RNA titer</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708733
org study id: 101001-62-010
nct id: NCT01708733
lead sponsor: 
has dmc: Yes
The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on
      HCV Carrier With Abnormal Liver Function.
percentage of change on HCV RNA titer and liver function (GPT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: HCV RNA titer
time frame: 6 weeks
measure: Serum GPT level
time frame: 6 weeks
measure: WHOQOL-BREF
time frame: 6 weeks
arm group label: KSY diluted
arm group type: Placebo Comparator
description: KSY diluted, 100mg decoction by mouth per day for 6 weeks
arm group label: KSY
arm group type: Experimental
description: KSY, 100mg decoction by mouth per day for 6 weeks
intervention type: Drug
intervention name: KSY
description: Chinese herbal formula
arm group label: KSY
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei City Hospital
investigator full name: Chung-Hua Hsu
investigator title: chief medical officer