<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/NCT04500210</url>
  </required_header>
  <id_info>
    <org_study_id>Tr-01</org_study_id>
    <nct_id>NCT04500210</nct_id>
  </id_info>
  <brief_title>Comparative Study of Turmeric Extract in Patients With Arthrosis.</brief_title>
  <official_title>A Double-blind, Randomized, Parallel Group, Phase III Comparative Study of Turmeric Extract and Placebo to Patients With Mild to Moderate Arthrosis of the Knee and or Hip.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaj Winther Hansen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to test if an extract of Turmeric can alleviate symptoms of&#xD;
      osteoarthritis in volunteers with osteoarthritis of the hip and or knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The included volunteers, who are devided into two groups either placebo or turmeric extract,&#xD;
      will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In&#xD;
      addition different aspects of quality of life will be evaluated and the consumption of rescue&#xD;
      medication will be recorded in patients personal diary.&#xD;
&#xD;
      The treatment period is 3 month with the posibility to continue for an additional 3 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">September 7, 2020</completion_date>
  <primary_completion_date type="Actual">September 7, 2020</primary_completion_date>
  <phase>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>
    <intervention_model_description>Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>3 month</time_frame>
    <description>Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>6 month</time_frame>
    <description>Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADL (Activity of daily living)</measure>
    <time_frame>3 month</time_frame>
    <description>Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADL (Activity of daily living)</measure>
    <time_frame>6 month</time_frame>
    <description>Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rescue medication</measure>
    <time_frame>3 month</time_frame>
    <description>Consumption of rescue medication from diaries (mg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rescue medication</measure>
    <time_frame>6 month</time_frame>
    <description>Consumption of rescue medication from diaries (mg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stiffness of joints</measure>
    <time_frame>3 month</time_frame>
    <description>Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stiffness of joints</measure>
    <time_frame>6 month</time_frame>
    <description>Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The volunteer evaluation of Global Disease Severity (PGAD)</measure>
    <time_frame>3 month</time_frame>
    <description>PGAD is measured on a 100 mm VAS scale (higher values worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The volunteer evaluation of Global Disease Severity (PGAD)</measure>
    <time_frame>6 month</time_frame>
    <description>PGAD is measured on a 100 mm VAS scale (higher values worse)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>SF-12 (Quality of life)</measure>
    <time_frame>3 month</time_frame>
    <description>Quality of life estimated on a numerical scale (1-3 and 1-6)</description>
  </other_outcome>
  <other_outcome>
    <measure>SF-12 (quality of life)</measure>
    <time_frame>6 month</time_frame>
    <description>Quality of life estimated on a numerical scale (1-3 and 1-6)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Arthralgia</condition>
  <condition>Stiffness of Unspecified Joint, Not Elsewhere Classified</condition>
  <condition>Disturbance of Activity and Attention</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>one capsule daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Turmeric extract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one capsule daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo in gelatin capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Turmeric</intervention_name>
    <description>Turmeric in gelatin capsules</description>
    <arm_group_label>Turmeric extract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Volunteers&#xD;
&#xD;
          -  40 years of age or more&#xD;
&#xD;
          -  Osteoarthritis of the hip and or the knee&#xD;
&#xD;
          -  Suffering from pain in the hip and or knee -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If volunteers are on a waiting list for hip or knee surgery&#xD;
&#xD;
          -  If the volunteers are involved in an other clinical trial&#xD;
&#xD;
          -  If the volunteers are taking other herbal remedies, which canhav influende on #&#xD;
             Osteoarthritis.&#xD;
&#xD;
          -  Abusers of alcohol and drugs&#xD;
&#xD;
          -  Volunteers not easy to cope with&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaj W Hansen, Prof, DMSCi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports</name>
      <address>
        <city>Copenhagen</city>
        <zip>1958 Frb. C</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Kaj Winther Hansen</investigator_full_name>
    <investigator_title>professor, MD, DMsCi</investigator_title>
  </responsible_party>
  <keyword>Arthralgia, stiffness of joints, quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthralgia</mesh_term>
    <mesh_term>Osteoarthritis</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/NCT04500210
org study id: Tr-01
nct id: NCT04500210
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to test if an extract of Turmeric can alleviate symptoms of
      osteoarthritis in volunteers with osteoarthritis of the hip and or knee.
The included volunteers, who are devided into two groups either placebo or turmeric extract,
      will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In
      addition different aspects of quality of life will be evaluated and the consumption of rescue
      medication will be recorded in patients personal diary.

      The treatment period is 3 month with the posibility to continue for an additional 3 month.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain
time frame: 3 month
description: Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
measure: Pain
time frame: 6 month
description: Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
measure: ADL (Activity of daily living)
time frame: 3 month
description: Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
measure: ADL (Activity of daily living)
time frame: 6 month
description: Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
measure: Rescue medication
time frame: 3 month
description: Consumption of rescue medication from diaries (mg)
measure: Rescue medication
time frame: 6 month
description: Consumption of rescue medication from diaries (mg)
measure: Stiffness of joints
time frame: 3 month
description: Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
measure: Stiffness of joints
time frame: 6 month
description: Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
measure: The volunteer evaluation of Global Disease Severity (PGAD)
time frame: 3 month
description: PGAD is measured on a 100 mm VAS scale (higher values worse)
measure: The volunteer evaluation of Global Disease Severity (PGAD)
time frame: 6 month
description: PGAD is measured on a 100 mm VAS scale (higher values worse)
measure: SF-12 (Quality of life)
time frame: 3 month
description: Quality of life estimated on a numerical scale (1-3 and 1-6)
measure: SF-12 (quality of life)
time frame: 6 month
description: Quality of life estimated on a numerical scale (1-3 and 1-6)
arm group label: Placebo
arm group type: Placebo Comparator
description: one capsule daily
arm group label: Turmeric extract
arm group type: Active Comparator
description: one capsule daily
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo in gelatin capsules
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Turmeric
description: Turmeric in gelatin capsules
arm group label: Turmeric extract
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kaj W Hansen, Prof, DMSCi
role: Principal Investigator
affiliation: University of Copenhagen
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Kaj Winther Hansen
investigator title: professor, MD, DMsCi
mesh term: Arthralgia
mesh term: Osteoarthritis