<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/NCT03757611</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2017-02</org_study_id>
    <nct_id>NCT03757611</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Tabetri on Osteoarthritis</brief_title>
  <official_title>A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutribiotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Neonutra</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jaseng Medical Foundation</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>
      This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical&#xD;
      trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is prospectively conducted to investigate the efficacy and safety of tabetri in&#xD;
      patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine&#xD;
      (Gangnam, Haeundae, Daejeon, and Bucheon).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS (Visual Analogue Scale)</measure>
    <time_frame>Change of the week 6 and 12 from baseline</time_frame>
    <description>VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of &quot;no pain at all&quot; and &quot;worst pain imaginable.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>K-WOMAC (Korean-Western Ontario and McMaster Universities)</measure>
    <time_frame>Change of the week 6 and 12 from baseline</time_frame>
    <description>K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KSF-36 (Korean-Short Form Health Survey 36)</measure>
    <time_frame>Change of the week 6 and 12 from baseline</time_frame>
    <description>KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject's global impression of change scale</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject&#xD;
Level of Quality&#xD;
Excellent (category 1): substantial overall improvement of symptoms&#xD;
Good (category 2): overall improvement of symptoms&#xD;
Neutral (category 3): no change compared with before&#xD;
Worse (category 4): overall deterioration of symptoms&#xD;
Very much worse (category 5): substantial overall deterioration of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's global impression of change scale</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator&#xD;
Level of Quality&#xD;
Excellent (category 1): substantial overall improvement of symptoms&#xD;
Good (category 2): overall improvement of symptoms&#xD;
Neutral (category 3): no change compared with before&#xD;
Worse (category 4): overall deterioration of symptoms&#xD;
Very much worse (category 5): substantial overall deterioration of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ESR (Erythrocyte sedimentation rate)</measure>
    <time_frame>Change of the week 12 from baseline</time_frame>
    <description>ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP (C-reactive protein)</measure>
    <time_frame>Change of the week 12 from baseline</time_frame>
    <description>CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>tabetri</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tabetri capsule will be administered orally twice daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule will be administered orally twice daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tabetri capsule</intervention_name>
    <description>1,000 mg/capsule (Taheebo extract 600 mg/day)</description>
    <arm_group_label>tabetri</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo capsule</intervention_name>
    <description>1,000 mg/capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 40 ~ 75 years of age&#xD;
&#xD;
          -  VAS (Visual Analogue Scale) over 30mm&#xD;
&#xD;
          -  Kellgren &amp; Lawrence Grade I~II by X-ray&#xD;
&#xD;
          -  Subject who agrees to participate in this clinical trial by themselves and signs the&#xD;
             Informed Consent Form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia,&#xD;
             systemic lupus erythematosus, septic arthritis, gout)&#xD;
&#xD;
          -  Joint space under 2 mm by X-ray&#xD;
&#xD;
          -  Kellgren &amp; Lawrence Grade over III with osteophyte, irregularly-shaped auricular&#xD;
             surfaces, or subchondral bone cyst by X-ray&#xD;
&#xD;
          -  Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases,&#xD;
             tumor diseases&#xD;
&#xD;
          -  Subjects having gastrointestinal diseases&#xD;
&#xD;
          -  Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)&#xD;
&#xD;
          -  Patients with TSH &lt;= 0.1 uIU/mL or &gt;= 10 uIU/mL&#xD;
&#xD;
          -  Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of&#xD;
             the normal values)&#xD;
&#xD;
          -  Subjects have attended abnormal values at creatinine (2 times excess at upper limit of&#xD;
             the normal values)&#xD;
&#xD;
          -  Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months&#xD;
&#xD;
          -  Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to&#xD;
             screening&#xD;
&#xD;
          -  Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)&#xD;
&#xD;
          -  History of osteoarthritis treatment therapy within 2 weeks prior to screening&#xD;
&#xD;
          -  Have participated in another clinical trial within the 3 months prior to screening&#xD;
&#xD;
          -  Subjects who have hypersensitivity history about investigational product&#xD;
&#xD;
          -  Have difficulty to be participated in this clinical trial by investigator's decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Hyuk Ha, KMD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bucheon Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haeundae Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daejeon Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</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>Osteoarthritis</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/NCT03757611
org study id: JS-CT-2017-02
nct id: NCT03757611
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical
      trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.
This study is prospectively conducted to investigate the efficacy and safety of tabetri in
      patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine
      (Gangnam, Haeundae, Daejeon, and Bucheon).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: VAS (Visual Analogue Scale)
time frame: Change of the week 6 and 12 from baseline
description: VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable."
measure: K-WOMAC (Korean-Western Ontario and McMaster Universities)
time frame: Change of the week 6 and 12 from baseline
description: K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
measure: KSF-36 (Korean-Short Form Health Survey 36)
time frame: Change of the week 6 and 12 from baseline
description: KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.
measure: Subject's global impression of change scale
time frame: 6 and 12 weeks
description: The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject
Level of Quality
Excellent (category 1): substantial overall improvement of symptoms
Good (category 2): overall improvement of symptoms
Neutral (category 3): no change compared with before
Worse (category 4): overall deterioration of symptoms
Very much worse (category 5): substantial overall deterioration of symptoms
measure: Investigator's global impression of change scale
time frame: 6 and 12 weeks
description: The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator
Level of Quality
Excellent (category 1): substantial overall improvement of symptoms
Good (category 2): overall improvement of symptoms
Neutral (category 3): no change compared with before
Worse (category 4): overall deterioration of symptoms
Very much worse (category 5): substantial overall deterioration of symptoms
measure: ESR (Erythrocyte sedimentation rate)
time frame: Change of the week 12 from baseline
description: ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
measure: CRP (C-reactive protein)
time frame: Change of the week 12 from baseline
description: CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
arm group label: tabetri
arm group type: Experimental
description: Tabetri capsule will be administered orally twice daily for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule will be administered orally twice daily for 12 weeks
intervention type: Dietary Supplement
intervention name: Tabetri capsule
description: 1,000 mg/capsule (Taheebo extract 600 mg/day)
arm group label: tabetri
intervention type: Dietary Supplement
intervention name: Placebo capsule
description: 1,000 mg/capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: In-Hyuk Ha, KMD, MPH
role: Principal Investigator
affiliation: Jaseng Medical Foundation
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: Undecided