<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/NCT02988232</url>
  </required_header>
  <id_info>
    <org_study_id>ISEE_2015_WRMD</org_study_id>
    <nct_id>NCT02988232</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain</brief_title>
  <acronym>WRMD</acronym>
  <official_title>Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gachon University Gil Oriental Medical Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sangji University Oriental Medical Center, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Semyung University Korean Medicine Hospital in Chungju, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daejeon University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gachon University Gil Oriental Medical Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Purpose of this trial is to investigate the efficacy and safety of&#xD;
      Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With&#xD;
      Work-related Chronic Low Back Pain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Numeric Rating Scale of Pain</measure>
    <time_frame>Screening Visit, At baseline, week 2, 4, 6, 8</time_frame>
    <description>A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 'Roland Morris Disability Questionnaire'</measure>
    <time_frame>Screening Visit, At baseline, week 2, 4, 6, 8</time_frame>
    <description>This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in European Quality of life 5 Dimension</measure>
    <time_frame>Screening Visit, At baseline, week 2, 4, 6, 8</time_frame>
    <description>The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Workplace</condition>
  <arm_group>
    <arm_group_label>Treatment(SGHH)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Admission to Sogyeonghwalhyeol-tang granule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>admission to placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sogyeonghwalhyeol-tang</intervention_name>
    <description>herbal extract</description>
    <arm_group_label>Treatment(SGHH)</arm_group_label>
    <other_name>SGHH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>extract powder with same appearance, odor and color as SGHH</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients with chief complaint of low back pain in oriental rehabilitation medical&#xD;
             center&#xD;
&#xD;
          -  Age 19 - 65&#xD;
&#xD;
          -  Workplace Vulnerable populations(hospital workers, office worker, blue collar workers,&#xD;
             transit workers)&#xD;
&#xD;
          -  Patients must include all of the following symptoms:&#xD;
&#xD;
               -  Those who have 4 ~7 cm of VAS pain score;&#xD;
&#xD;
               -  Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA&#xD;
                  questionnaire&#xD;
&#xD;
          -  Ability to have normal communication&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with pain duration of 3 months or less&#xD;
&#xD;
          2. Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test&#xD;
&#xD;
          3. Patients diagnosed with serious pathology(s) which may cause low back pain (e.g.&#xD;
             spinal metastasis of tumor(s), acute fracture, etc)&#xD;
&#xD;
          4. Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher&#xD;
             level)&#xD;
&#xD;
          5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or&#xD;
             other medication(s) that may interfere with study results&#xD;
&#xD;
          6. Patients with history of spinal surgery&#xD;
&#xD;
          7. Patients with more severe pain than pain caused by low back pain&#xD;
&#xD;
          8. Those who do not (cannot) abide by treatment and follow up due to the mental illness&#xD;
             such as behavior disorder, depression, anxiety neurosis etc.&#xD;
&#xD;
          9. Patients with history of Medical Malpractice Case&#xD;
&#xD;
         10. Patients with treatment history of low back pain within 1 month either KM or WM&#xD;
&#xD;
         11. Patients participating in other clinical studies within 3 months&#xD;
&#xD;
         12. Pregnant patients or patients with plans of pregnancy or lactating patients&#xD;
&#xD;
         13. Patients disagree to sign the informed consent form&#xD;
&#xD;
         14. Patients deemed unsuitable for participating the trial by the researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun-Kyung Song, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University of Oriental Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gachon University Gil Oriental Medical Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gachon University Gil Oriental Medical Hospital</investigator_affiliation>
    <investigator_full_name>Yun-Kyung Song</investigator_full_name>
    <investigator_title>KMD PhD</investigator_title>
  </responsible_party>
  <keyword>Work Related Chronic Low Back Pain</keyword>
  <keyword>Korean Medicine</keyword>
  <keyword>Sogyeonghwalhyeol-tang</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT02988232
org study id: ISEE_2015_WRMD
nct id: NCT02988232
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The Purpose of this trial is to investigate the efficacy and safety of
      Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain
Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With
      Work-related Chronic Low Back Pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from Baseline in Numeric Rating Scale of Pain
time frame: Screening Visit, At baseline, week 2, 4, 6, 8
description: A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.
measure: Change from Baseline in 'Roland Morris Disability Questionnaire'
time frame: Screening Visit, At baseline, week 2, 4, 6, 8
description: This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
measure: Change from Baseline in European Quality of life 5 Dimension
time frame: Screening Visit, At baseline, week 2, 4, 6, 8
description: The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.
arm group label: Treatment(SGHH)
arm group type: Experimental
description: Admission to Sogyeonghwalhyeol-tang granule
arm group label: Placebo
arm group type: Placebo Comparator
description: admission to placebo
intervention type: Drug
intervention name: Sogyeonghwalhyeol-tang
description: herbal extract
arm group label: Treatment(SGHH)
other name: SGHH
intervention type: Drug
intervention name: Placebo
description: extract powder with same appearance, odor and color as SGHH
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yun-Kyung Song, PhD
role: Principal Investigator
affiliation: Gachon University of Oriental Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gachon University Gil Oriental Medical Hospital
investigator full name: Yun-Kyung Song
investigator title: KMD PhD
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided