<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/NCT02983669</url>
  </required_header>
  <id_info>
    <org_study_id>94-7648</org_study_id>
    <nct_id>NCT02983669</nct_id>
  </id_info>
  <brief_title>The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease</brief_title>
  <acronym>ThymeLiv</acronym>
  <official_title>The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria&#xD;
      multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease&#xD;
      (NAFLD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared&#xD;
      with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria.&#xD;
      Investigators measure anthropometric and laboratory parameters including fasting blood sugar,&#xD;
      insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90&#xD;
      days later. Patients are divided into two equal groups. Intervention group in addition to&#xD;
      diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder&#xD;
      daily for 90 days. Placebo group in addition to the same recommendations for diet and&#xD;
      exercise, receives placebo capsules twice daily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 20, 2017</primary_completion_date>
  <phase>N/A</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>Change in ALT (Alanin aminotransferase) level</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in AST (Aspartate aminotransferase) level</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood sugar (FBS)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gama GT (γ-glutamyl transpeptidase) level</measure>
    <time_frame>3 monyhs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin level</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Fatty Liver</condition>
  <condition>Fatty Liver, Nonalcoholic</condition>
  <arm_group>
    <arm_group_label>Thyme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Wheat powder capsule 350 mg twice daily for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Thyme</intervention_name>
    <description>Thyme capsule 350 mg twice daily</description>
    <arm_group_label>Thyme</arm_group_label>
    <other_name>Shirazi's Thyme</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule 350 mg twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 20-65 years&#xD;
&#xD;
          -  Body mass index: 18-35 kg/m2&#xD;
&#xD;
          -  Serum ALT level: &gt;45 U/Lit. in Males, &gt;29 U/Lit. in Females&#xD;
&#xD;
          -  Grade &gt;=1 fatty liver in liver sonography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and Lactation&#xD;
&#xD;
          -  Acute or chronic liver failure&#xD;
&#xD;
          -  Acute or chronic renal failure&#xD;
&#xD;
          -  Autoimmune or viral hepatitis&#xD;
&#xD;
          -  Wilson's disease&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Alcoholism&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Hypothyroidism or hyperthyroidism&#xD;
&#xD;
          -  Drug used in last three months: OCP, metformin, vitamin E, ursodeoxycholic acid,&#xD;
             glucocorticoids, thiazolidenediones.&#xD;
&#xD;
          -  History of allergic reactions to Thyme&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Majid Nimruzi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center for Traditional Medicine &amp; History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mojtaba Heydari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center for Traditional Medicine &amp; History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nasrin dokht Zamani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center for Traditional Medicine &amp; History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shahid Motahhari Clinic, Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <state>Fars</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mesbah Shams, MD</investigator_full_name>
    <investigator_title>Associate professor of Internal medicine and Endocrinology</investigator_title>
  </responsible_party>
  <keyword>Thymus Plant</keyword>
  <keyword>Multiflotriol [Supplementary Concept]</keyword>
  <keyword>Zataria multiflora</keyword>
  <keyword>Complementary Therapies</keyword>
  <keyword>Herbal Medicine</keyword>
  <keyword>Medicine, traditional</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02983669
org study id: 94-7648
nct id: NCT02983669
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria
      multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease
      (NAFLD).
In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared
      with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria.
      Investigators measure anthropometric and laboratory parameters including fasting blood sugar,
      insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90
      days later. Patients are divided into two equal groups. Intervention group in addition to
      diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder
      daily for 90 days. Placebo group in addition to the same recommendations for diet and
      exercise, receives placebo capsules twice daily.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in ALT (Alanin aminotransferase) level
time frame: 3 months
measure: Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
time frame: 3 months
measure: Change in AST (Aspartate aminotransferase) level
time frame: 3 months
measure: Fasting blood sugar (FBS)
time frame: 3 months
measure: Change in Gama GT (γ-glutamyl transpeptidase) level
time frame: 3 monyhs
measure: Fasting insulin level
time frame: 3 months
measure: Body weight
time frame: 3 months
measure: Waist circumference
time frame: 3 months
measure: Hip circumference
time frame: 3 months
measure: Number of patients with adverse events
time frame: 4 months
arm group label: Thyme
arm group type: Experimental
description: Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Wheat powder capsule 350 mg twice daily for 3 months
intervention type: Dietary Supplement
intervention name: Thyme
description: Thyme capsule 350 mg twice daily
arm group label: Thyme
other name: Shirazi's Thyme
intervention type: Other
intervention name: Placebo
description: Placebo capsule 350 mg twice daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Majid Nimruzi, MD
role: Principal Investigator
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
last name: Mojtaba Heydari, MD
role: Principal Investigator
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
last name: Nasrin dokht Zamani, MD
role: Principal Investigator
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Mesbah Shams, MD
investigator title: Associate professor of Internal medicine and Endocrinology
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: Undecided