<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/NCT03017118</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001402</org_study_id>
    <nct_id>NCT03017118</nct_id>
  </id_info>
  <brief_title>Turmeric for Patients With Basal Joint Arthritis</brief_title>
  <official_title>A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 assess whether the use of a commercially available nutraceutical,&#xD;
      turmeric, is an effective option to manage pain and stiffness in patients with basal joint&#xD;
      arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric&#xD;
      on basal joint arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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 baseline pain intensity</measure>
    <time_frame>Enrollment, 6 weeks, and 3 months</time_frame>
    <description>0-10 ordinal rating of pain intensity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline disability</measure>
    <time_frame>Enrollment, 6 weeks, and 3 months</time_frame>
    <description>Disability measured by the QuickDASH</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Thumb Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Turmeric</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Turmeric</intervention_name>
    <description>Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.</description>
    <arm_group_label>Turmeric</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects in the control group will receive a placebo 3 times per day for 6 weeks.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 years of age or older&#xD;
&#xD;
          -  English fluency and literacy&#xD;
&#xD;
          -  Seeking care for basal joint pain&#xD;
&#xD;
          -  Tender over basal joint&#xD;
&#xD;
          -  Positive distraction rotation test (rotation of the thumb metacarpal base while&#xD;
             applying axial traction)&#xD;
&#xD;
          -  Radiographic evidence of Eaton stage 1 and 2 only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary gains (litigations or worker compensation) procedures that may interfere&#xD;
             with patients' motivation for treatment&#xD;
&#xD;
          -  Inability or unwillingness to participate in a trial study&#xD;
&#xD;
          -  Rheumatoid Arthritis or other inflammatory disorder diagnoses&#xD;
&#xD;
          -  Post-traumatic osteoarthritis&#xD;
&#xD;
          -  Patients on Coumadin/Steroids/NSAIDs/Tylenol&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Basal joint arthritis of Eaton stage 3&#xD;
&#xD;
          -  Patients seeking other treatment for their basal joint arthritis (splint,&#xD;
             corticosteroid injection, surgery)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neal Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Neal Chen, M.D.</last_name>
    <phone>617-726-4700</phone>
    <email>nchen1@mgh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karan Amin, BA</last_name>
    <email>kamin2@mgh.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neal Chen, MD</last_name>
      <phone>617-726-4700</phone>
      <email>nchen1@mgh.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kiera Lunn, BSc</last_name>
      <phone>6177261569</phone>
      <email>klunn@mgh.harvard.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 11, 2023</last_update_submitted>
  <last_update_submitted_qc>June 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Neal Chung-Jen Chen</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT03017118
org study id: 2016P001402
nct id: NCT03017118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess whether the use of a commercially available nutraceutical,
      turmeric, is an effective option to manage pain and stiffness in patients with basal joint
      arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric
      on basal joint arthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in baseline pain intensity
time frame: Enrollment, 6 weeks, and 3 months
description: 0-10 ordinal rating of pain intensity
measure: Change in baseline disability
time frame: Enrollment, 6 weeks, and 3 months
description: Disability measured by the QuickDASH
arm group label: Turmeric
arm group type: Experimental
description: Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
arm group label: Control
arm group type: Placebo Comparator
description: Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.
intervention type: Dietary Supplement
intervention name: Turmeric
description: Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
arm group label: Turmeric
intervention type: Other
intervention name: Placebo
description: Subjects in the control group will receive a placebo 3 times per day for 6 weeks.
arm group label: Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Chen, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Neal Chen, M.D.
phone: 617-726-4700
email: nchen1@mgh.harvard.edu
last name: Karan Amin, BA
email: kamin2@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Neal Chung-Jen Chen
investigator title: Medical Doctor
mesh term: Arthritis
mesh term: Osteoarthritis