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Efficacy, Safety, and Economic Evaluation of Adjuvant Herbal Medicine Treatment, Palmijihwang-hwan, for Chronic Low Back Pain: A Multicentered, Randomized, Assessor-blinded, Controlled Clinical Trial

Status Approved

  • First Submitted Date

    2018/07/02

  • Registered Date

    2018/07/12

  • Last Updated Date

    2018/07/10

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002998
    Unique Protocol ID 2018-0006
    Public/Brief Title Efficacy, Safety, and Economic Evaluation of Adjuvant Herbal Medicine Treatment, Palmijihwang-hwan, for Chronic Low Back Pain
    Scientific Title Efficacy, Safety, and Economic Evaluation of Adjuvant Herbal Medicine Treatment, Palmijihwang-hwan, for Chronic Low Back Pain: A Multicentered, Randomized, Assessor-blinded, Controlled Clinical Trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2018-0006
    Approval Date 2018-05-02
    Institutional Review Board Name Dongguk university Bundang Oriental Hospital's Institutional Review Board
    Institutional Review Board Address 268, Buljeong-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-710-3751
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Eunjung Kim
    Title Professor
    Telephone +82-31-710-3751
    Affiliation Dongguk University
    Address 30, Pildong-ro 1-gil, Jung-gu, Seoul, Korea
    Contact Person for Public Queries
    Name Eunjung Kim
    Title Professor
    Telephone +82-31-710-3751
    Affiliation Dongguk University
    Address 30, Pildong-ro 1-gil, Jung-gu, Seoul, Korea
    Contact Person for Updating Information
    Name Hyeryeon Kim
    Title researcher
    Telephone +82-31-710-3746
    Affiliation Dongguk University Bundang Oriental Hospital
    Address 268, Buljung-ro, Bundang-gu, Sungnam, Gyeongido, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 4
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-01 Anticipated
    Target Number of Participant 84
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Kyung Hee University Oriental Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-01 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Kyung Hee University Oriental Medicine Hospital at Gangdong
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-01 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Daegu Oriental Hospital of Daegu Haany University
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-01 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Dongguk University Bundang Oriental Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dongguk University Bundang Oriental Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Low back pain(LBP) is a symptom that everone experiences, and it is a pain syndrome in the lumbar region because of various causes rather than single disease. LBP is usually classified as acute, subacute, and chronic according to the duration of the pain. If the duration is less than six weeks, it is common to classify it as acute, subacute in six to 12 weeks, and chronic in more than 12 weeks.
    According to the survey conducted by the Ministry of Health and Welfare in 2015, 17.77% of the outpatients received korean medicine to treat LBP.  It was the most common single symptom. Korean medicine is seeking cures for chronic LBP through various methods such as acupuncture, herbal acupuncture, Chuna, and herbal medicine. 
    Currently, Palmijihwanghan is widely used as a treatment of LBP, but it is not receiving insurance benefits due to lack of data on efficacy and economic evaluation. 
    In this clinical trial, patients with chronic LBP will be given palmijihwanghan for six weeks. We will then compare changes in the pain score(VAS) to assess the effectiveness, safety, and economic evalutation of palmijihwanghan.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Investigator, Outcome Accessor
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    1. [Palmijihwanghan+Acupuncture] A combined treatment group
    (1) medicine(Palmijihwanghan) : Take one pill every six weeks, twice a day. Take an oral dose with water 30 minutes after breakfast and dinner everyday.
    (2) Acupuncture : The patients is treated with acupuncture in the prone postion just like in the control group. Use 0.25x 40mm disposable sterilized acupuncture needles (Donbang Acupuncture Company). A total of 15 acupoints are used as follows. Acupuncture is administered twice a week with 20 minutes.
    a. Local Acupuncture Points 
    - BL23, BL24, BL25, BL26 EX-B5 on both sided. 
    - GV3
    b. Distal Acupuncture Points 
    - BL40 and BL60 on both sided.
    
    2. Acupunture Treatment
    The patients is treated with acupuncture in the prone postion just like in the control group. Use 0.25x 40mm disposable sterilized acupuncture needles (Donbang Acupuncture Company). A total of 15 acupoints are used as follows. Acupuncture is administered twice a week with 20 minutes.
    a. Local Acupuncture Points 
    - BL23, BL24, BL25, BL26 EX-B5 on both sided. 
    - GV3
    b. Distal Acupuncture Points 
    - BL40 and BL60 on both sided.
    Number of Arms 2
    Arm 1

    Arm Label

    [Palmijihwanghan+Acupuncture] A combined treatment group

    Target Number of Participant

    42

    Arm Type

    Experimental

    Arm Description

    (1) medicine(Palmijihwanghan) : Take one pill every six weeks, twice a day. Take an oral dose with water 30 minutes after breakfast and dinner everyday.
    (2) Acupuncture : The patients is treated with acupuncture in the prone postion just like in the control group. Use 0.25x 40mm disposable sterilized acupuncture needles (Donbang Acupuncture Company). A total of 15 acupoints are used as follows. Acupuncture is administered twice a week with 20 minutes.
    a. Local Acupuncture Points 
    - BL23, BL24, BL25, BL26 EX-B5 on both sided. 
    - GV3
    b. Distal Acupuncture Points 
    - BL40 and BL60 on both sided.
    Arm 2

    Arm Label

    Acupunture Treatment

    Target Number of Participant

    42

    Arm Type

    Active comparator

    Arm Description

    The patients is treated with acupuncture in the prone postion just like in the control group. Use 0.25x 40mm disposable sterilized acupuncture needles (Donbang Acupuncture Company). A total of 15 acupoints are used as follows. Acupuncture is administered twice a week with 20 minutes.
    a. Local Acupuncture Points 
    - BL23, BL24, BL25, BL26 EX-B5 on both sided. 
    - GV3
    b. Distal Acupuncture Points 
    - BL40 and BL60 on both sided.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M54.56)Low back pain, lumbar region 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~65Year

    Description

    1. Male and female subjects aged from 19 to 65 
    2. Low Back Pain which lasted more than 3 months is main chief complaint 
    3. Pain and discomfort due to low back pain is greater than 4 on the 10-cm visual analog scale (VAS) for one week before the enrollment 
    4. Participants who signed the agreed consent to follow instructions voluntarily after listening to the detailed explanation of this clinical trial
    Exclusion Criteria
    1. Persons who have history of hypersensitive reactions of Palmijihwanghan's herb or herbal medicine.
    2. Those who have abnormalities in the lower neurological examination 
    3. Those who have cauda equine syndrome or neurological symptoms of sensory or motor paralysis which need surgical treatments. 
    4. Those who have history of the spinal surgery or plans for surgery during the clinical trial period 
    5. Neuromuscular scoliosis or neurodegenerative disease 
    6. Those with diagnosed diseases which can be the possible cause of back pain: vertebral fracture, inflammatory spondylitis, spinal infection, malignant tumor, etc. 
    7. Female subects who are pregnant, or are brease-feeding or has plans for pregnancy plan, or does not consent to the choice of appropriate method of contraception. 
    8. Those who have a weak stomach or is prone to diarrhea
    9. Person with genetic problems such as Galactose intolerance, Lappase lactase deficiency, or Glucose=galactose malabsorption.
    10. Those who received acupuncture, medication, physical therapy, or manipulation therapy related to back pain within the last 2 weeks
    11. Person with hepatotoxicity or nephrotoxicity(AST or ALT>2 x normal range, serum creatinine>2.0mg/dl) 
    12. Person with a history of heart disease, risk of hypertension or uncontrolled hypertension such as systolic blood pressure > 160mmHg or diastolic blood pressure < 100mmHg.
    13. Those who have more severe pain in another area other than the low back area
    14. Those who has participated in other clinical trials involving chronic low bac pain within the last month.
    15. If clinical trial investigators judges that it is inappropriate for the subject to be enrolled for a fair reason
    16. In case Korean medicine doctor in charge of testing is judged by diagnosis that the subject is not suitable for a Palmijihwanghan dose
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    pain scores (VAS)
    Timepoint
    Pain scores (VAS) at the end of arbitration visit (V12) of treatment compared to baseline(0주, V1)
    Secondary Outcome(s) 1
    Outcome
    Change of pain scores (VAS)
    Timepoint
    Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13)
    Secondary Outcome(s) 2
    Outcome
    the clinical relevances (MCID, reduction ratio of 2 points or more on VAS compared to the 0 week (V1)
    Timepoint
    Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13)
    Secondary Outcome(s) 3
    Outcome
    the clinical relevances (MCID, reduction ratio of VAS 30% or more compared to the 0 week (V1)
    Timepoint
    Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13)
    Secondary Outcome(s) 4
    Outcome
    the clinical relevances (MCID, reduction ratio of VAS 50% or more compared to the 0 week (V1)
    Timepoint
    Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13)
    Secondary Outcome(s) 5
    Outcome
    Change of Roland and Morris Disability Questionnaire (RMDQ) scores
    Timepoint
    Changes in Roland and Morris Disability Questionnaire (RMDQ) scores after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13)
    Secondary Outcome(s) 6
    Outcome
    Change of EuroQol (EQ-5D) scores
    Timepoint
    Changes in EuroQol (EQ-5D) scores after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13)
    Secondary Outcome(s) 7
    Outcome
    Cost-benefit analysis and cost-effectiveness analysis between the two groups.
    Timepoint
    Every visit from visit 1 to visit 12 and 4 weeks after end of arbitration
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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