<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/NCT01712373</url>
  </required_header>
  <id_info>
    <org_study_id>ASD-1270</org_study_id>
    <nct_id>NCT01712373</nct_id>
  </id_info>
  <brief_title>Ginseng in Treatment of Fatigue in Multiple Sclerosis</brief_title>
  <official_title>Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of&#xD;
      fatigue and Quality of Life of MS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the&#xD;
      world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System&#xD;
      (CNS) which affects individuals in the productive ages and causes a large burden for years to&#xD;
      come. Fatigue is a common complaint and one of the least understood symptoms of MS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">April 2011</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>at 3 months after treatment</time_frame>
    <description>Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality Of Life</measure>
    <time_frame>at 3 months after treatment</time_frame>
    <description>Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Ginseng</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ginseng, tablet, 250 mg, twice, 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ginseng</intervention_name>
    <description>it is kind of drug</description>
    <arm_group_label>Ginseng</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>it is placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria with a&#xD;
             baseline of Expanded Disability Status Score (EDSS)of less than 5.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior use of ginseng or any other tonic agents, glucocorticoids, warfarin, digoxin,&#xD;
             aspirin, furosemide, caffeine, ephedra and anti-platelet agents within one month prior&#xD;
             to enrollment;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  history of renal failure; and,&#xD;
&#xD;
          -  lack of appropriate adherence to the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mahboobe esfahani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD, Research Assistant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Al-zahra university hospital</name>
      <address>
        <city>Isfahan</city>
        <zip>7007</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://www.mui.ac.ir</url>
    <description>Isfahan university of medical science</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hamidreza Shemshaki</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Ginseng</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</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/NCT01712373
org study id: ASD-1270
nct id: NCT01712373
lead sponsor: 
has dmc: Yes
The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of
      fatigue and Quality of Life of MS patients.
Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the
      world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System
      (CNS) which affects individuals in the productive ages and causes a large burden for years to
      come. Fatigue is a common complaint and one of the least understood symptoms of MS
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fatigue
time frame: at 3 months after treatment
description: Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects.
measure: Quality Of Life
time frame: at 3 months after treatment
description: Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.
arm group label: Ginseng
arm group type: Active Comparator
description: Ginseng, tablet, 250 mg, twice, 3 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, tablet
intervention type: Drug
intervention name: Ginseng
description: it is kind of drug
arm group label: Ginseng
intervention type: Drug
intervention name: Placebo
description: it is placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mahboobe esfahani, MD
role: Principal Investigator
affiliation: MD, Research Assistant
facility: 
country: Iran, Islamic Republic of
url: http://www.mui.ac.ir
description: Isfahan university of medical science
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Hamidreza Shemshaki
investigator title: research assistant
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fatigue