<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/NCT04492670</url>
  </required_header>
  <id_info>
    <org_study_id>KOA</org_study_id>
    <nct_id>NCT04492670</nct_id>
  </id_info>
  <brief_title>Tui-na and Oral Chinese Medicine on KOA</brief_title>
  <official_title>The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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 study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on&#xD;
      the treatment of KOA.&#xD;
&#xD;
      This is a prospective, randomized wait-list controlled trial in patients with knee&#xD;
      osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly&#xD;
      assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have&#xD;
      4-week of treatment, and then a 4-week follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4,&#xD;
      and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western&#xD;
      Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed&#xD;
      and filled up at different timepoints. The treatment group will receive both Tui-na and study&#xD;
      medication and the wait-list control group will receive Tui-na alone. CMPs will provide&#xD;
      consultation under Chinese medicine theory. Study medication compliance and adverse events&#xD;
      will also be assessed at each visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>4 weeks</time_frame>
    <description>to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-EL questionnaire</measure>
    <time_frame>8 weeks</time_frame>
    <description>to assess health-related quality of life, one part is descriptive has 5 response level, the other part is VAS which ranges from 0 to 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>at 2 weeks and 8 weeks</time_frame>
    <description>to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Tui-na and oral Chinese medicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tui-na</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>8 sessions of 20 minutes Tui-na for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tui-na</intervention_name>
    <description>For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.</description>
    <arm_group_label>Tui-na</arm_group_label>
    <arm_group_label>Tui-na and oral Chinese medicine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Du-Huo-Ji-Sheng-Tang (DHJST)</intervention_name>
    <description>This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.</description>
    <arm_group_label>Tui-na and oral Chinese medicine</arm_group_label>
    <other_name>Herbal granules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. of either gender (female must have either sterilization done or menopause)&#xD;
&#xD;
          2. ≥50years of age&#xD;
&#xD;
          3. meet the criteria of KOA according to the American College of Rheumatology&#xD;
&#xD;
               -  Knee pain, and&#xD;
&#xD;
               -  Any 4 of the following,&#xD;
&#xD;
                    -  ≥ 50 years of age&#xD;
&#xD;
                    -  Less than 30 minutes of morning stiffness&#xD;
&#xD;
                    -  Crepitus on active motion&#xD;
&#xD;
                    -  Bony tenderness&#xD;
&#xD;
                    -  Bony enlargement&#xD;
&#xD;
                    -  No palpable warmth of synovium&#xD;
&#xD;
                    -  Osteophytes (Radiographic findings)&#xD;
&#xD;
          4. with WOMAC score ≥ 39&#xD;
&#xD;
          5. with written informed consentform signed (for illiterate subjects, their next-of-kin&#xD;
             or an impartial witness will sign with subjects' permission)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known knee pain caused by infection, malignant or autoimmune diseases&#xD;
&#xD;
          2. Knee surgery or arthroscopy in the past year&#xD;
&#xD;
          3. Chondroprotective or intra-articular injection in the past 4 months&#xD;
&#xD;
          4. Systemic corticoid treatment in the past 4 months&#xD;
&#xD;
          5. Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones,&#xD;
             antiarrhythmic drugs or diuretics drugs&#xD;
&#xD;
          6. Subject with uncontrolled hypertension&#xD;
&#xD;
          7. Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks&#xD;
&#xD;
          8. Known history of mental disorder&#xD;
&#xD;
          9. Known history of serious acute organic disease&#xD;
&#xD;
         10. Renal or liver function impairment&#xD;
&#xD;
         11. Known allergy to or have drug interaction with the study herb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhixiu Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof. Lin Zhixiu</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Knee osteoarthritis, Tui-na, Chinese medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04492670
org study id: KOA
nct id: NCT04492670
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on
      the treatment of KOA.

      This is a prospective, randomized wait-list controlled trial in patients with knee
      osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly
      assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have
      4-week of treatment, and then a 4-week follow-up.
The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4,
      and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western
      Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed
      and filled up at different timepoints. The treatment group will receive both Tui-na and study
      medication and the wait-list control group will receive Tui-na alone. CMPs will provide
      consultation under Chinese medicine theory. Study medication compliance and adverse events
      will also be assessed at each visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: 4 weeks
description: to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
measure: EQ-5D-EL questionnaire
time frame: 8 weeks
description: to assess health-related quality of life, one part is descriptive has 5 response level, the other part is VAS which ranges from 0 to 100
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: at 2 weeks and 8 weeks
description: to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
arm group label: Tui-na and oral Chinese medicine
arm group type: Experimental
description: 8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks
arm group label: Tui-na
arm group type: Other
description: 8 sessions of 20 minutes Tui-na for 4 weeks
intervention type: Procedure
intervention name: Tui-na
description: For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.
arm group label: Tui-na
arm group label: Tui-na and oral Chinese medicine
intervention type: Drug
intervention name: Du-Huo-Ji-Sheng-Tang (DHJST)
description: This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
arm group label: Tui-na and oral Chinese medicine
other name: Herbal granules
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Zhixiu Lin, PhD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Prof. Lin Zhixiu
investigator title: Associate professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No