<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/NCT01680003</url>
  </required_header>
  <id_info>
    <org_study_id>CT11-03</org_study_id>
    <nct_id>NCT01680003</nct_id>
  </id_info>
  <brief_title>Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease</brief_title>
  <acronym>Hepar-P</acronym>
  <official_title>A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of HEPAR-P Capsule for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Laboratories Sdn Bhd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Laboratories Sdn Bhd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, double blind, parallel group placebo controlled randomised trial&#xD;
      designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri&#xD;
      (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a&#xD;
      treatment period of 48 weeks&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2013</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in serum aspartate aminotransferase and alanine aminotransferase levels</measure>
    <time_frame>48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events reporting, physical examinations and laboratory tests</measure>
    <time_frame>48 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Non-alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Hepar-P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hepar-P: Two capsules (250mg x 2), three times daily, orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for Hepar-P</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: Two capsules, three times daily, orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hepar-P</intervention_name>
    <arm_group_label>Hepar-P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Hepar-P</intervention_name>
    <arm_group_label>Placebo for Hepar-P</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant females age 18 years or older&#xD;
&#xD;
          -  Written informed consent obtained from patient or parents/ guardian&#xD;
&#xD;
          -  Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)&#xD;
             levels but less than 2.5times the upper limit of the normal range&#xD;
&#xD;
          -  Patients with liver biopsy confirmed possible or definite steatohepatitis within the&#xD;
             past 12 months prior to enrolment into the trial&#xD;
&#xD;
          -  Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with&#xD;
             activity score ≥5&#xD;
&#xD;
          -  A score of at least 1 for hepatocellular ballooning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing woman or women of childbearing potential except if&#xD;
             post-menopausal, surgically sterile or using accepted method(s) of birth control or&#xD;
             having negative pregnancy test&#xD;
&#xD;
          -  Participation in any trial in which the patient received an investigational product&#xD;
             within 30 days preceding the screening phase of this study&#xD;
&#xD;
          -  Those persons directly involved in the conduct of the study&#xD;
&#xD;
          -  Alcohol consumption of more than 20g per day for women or more than 30g per day for&#xD;
             men for at least 3 consecutive months during the previous 5 years, as assessed with&#xD;
             the use of the Lifetime Drinking History questionnaire and the interview version of&#xD;
             the Alcohol Use and Disorders Identification Test (AUDIT)&#xD;
&#xD;
          -  History of cirrhosis, hepatitis C or other liver diseases&#xD;
&#xD;
          -  History of heart failure (New York Association Class II to IV)&#xD;
&#xD;
          -  History of taking medications known to cause steatohepatitis&#xD;
&#xD;
          -  Any serious medical conditions or disability, which in the opinion of the&#xD;
             investigator, would interfere with treatment or assessment or preclude completion of&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad Radzi Abu Hassan, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sultanah Bahiyah Hospital, Alor Star</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tan Soek Siam, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Selayang Hospital, Selangor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tee Hoi Poh, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tengku Ampuau Afzan Hospital, Kuantan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosaida Mohd Said, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ampang Hospital, Selangor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shashi Kumar Bhaskaran, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kuala Lumpur Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jayaram Menon, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Elizaberth Hospital, Sabah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sultamah Bahiyah Hospital</name>
      <address>
        <city>Alor Setar</city>
        <state>Kedah</state>
        <zip>05460</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muhammad Radzi Abu Hassan, Dr</last_name>
      <phone>+604-7407814</phone>
      <email>drradzi91@yahoo.co.uk</email>
    </contact>
    <investigator>
      <last_name>Muhammad Radzi Abu Hassan, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kuala Lumpur Hospital</name>
      <address>
        <city>Wilayah Persekutuan</city>
        <state>Kuala Lumpur</state>
        <zip>50586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shashi Kumar Kumar Bhaskaran, Dr</last_name>
      <phone>03-26155555</phone>
      <phone_ext>5691</phone_ext>
      <email>dr_shashi@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Shashi Kumar Menon Bhaskaran, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tengku Ampuan Afzan Hospital</name>
      <address>
        <city>Kuantan</city>
        <state>Pahang</state>
        <zip>25100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tee Hoi Poh, Dr</last_name>
      <phone>09-5133334</phone>
      <email>hptee@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Tee Hoi Poh, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Elizaberth Hospital</name>
      <address>
        <city>Kota Kinabalu</city>
        <state>Sabah</state>
        <zip>88586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jayaram Menon, Dr</last_name>
      <phone>+(6)088-517555</phone>
      <phone_ext>7117</phone_ext>
      <email>drmjayaram@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jayaram Menon, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ampang Hospital</name>
      <address>
        <city>Selangor</city>
        <zip>68000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosaida Mohd Said, Dr</last_name>
      <phone>03-42896155</phone>
      <email>drrosaida@moh.gov.my</email>
    </contact>
    <investigator>
      <last_name>Rosaida Mohd Said, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>April 10, 2013</last_update_submitted>
  <last_update_submitted_qc>April 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01680003
org study id: CT11-03
nct id: NCT01680003
lead sponsor: 
has dmc: No
This is a multi-center, double blind, parallel group placebo controlled randomised trial
      designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri
      (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a
      treatment period of 48 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
time frame: 48 weeks
measure: Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score
time frame: 48 weeks
measure: Adverse events reporting, physical examinations and laboratory tests
time frame: 48 weeks
arm group label: Hepar-P
arm group type: Experimental
description: Hepar-P: Two capsules (250mg x 2), three times daily, orally
arm group label: Placebo for Hepar-P
arm group type: Placebo Comparator
description: Placebo: Two capsules, three times daily, orally
intervention type: Drug
intervention name: Hepar-P
arm group label: Hepar-P
intervention type: Drug
intervention name: Placebo for Hepar-P
arm group label: Placebo for Hepar-P
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Muhammad Radzi Abu Hassan, Dr
role: Principal Investigator
affiliation: Sultanah Bahiyah Hospital, Alor Star
last name: Tan Soek Siam, Dr
role: Principal Investigator
affiliation: Selayang Hospital, Selangor
last name: Tee Hoi Poh, Dr
role: Principal Investigator
affiliation: Tengku Ampuau Afzan Hospital, Kuantan
last name: Rosaida Mohd Said, Dr
role: Principal Investigator
affiliation: Ampang Hospital, Selangor
last name: Shashi Kumar Bhaskaran, Dr
role: Principal Investigator
affiliation: Kuala Lumpur Hospital
last name: Jayaram Menon, Dr
role: Principal Investigator
affiliation: Queen Elizaberth Hospital, Sabah
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Malaysia
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease