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
CRIS Registration Number |
KCT0002998 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 4 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Dongguk University Bundang Oriental Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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 |
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Arm Type Active comparator |
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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
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M54.56)Low back pain, lumbar region |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~65Year |
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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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | pain scores (VAS) |
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Timepoint | Pain scores (VAS) at the end of arbitration visit (V12) of treatment compared to baseline(0주, V1) |
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Secondary Outcome(s) 1 | ||
Outcome | Change of pain scores (VAS) |
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Timepoint | Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13) |
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Secondary Outcome(s) 2 | ||
Outcome | the clinical relevances (MCID, reduction ratio of 2 points or more on VAS compared to the 0 week (V1) |
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Timepoint | Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13) |
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Secondary Outcome(s) 3 | ||
Outcome | the clinical relevances (MCID, reduction ratio of VAS 30% or more compared to the 0 week (V1) |
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Timepoint | Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13) |
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Secondary Outcome(s) 4 | ||
Outcome | the clinical relevances (MCID, reduction ratio of VAS 50% or more compared to the 0 week (V1) |
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Timepoint | Changes in pain score (VAS) after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13) |
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Secondary Outcome(s) 5 | ||
Outcome | Change of Roland and Morris Disability Questionnaire (RMDQ) scores |
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Timepoint | Changes in Roland and Morris Disability Questionnaire (RMDQ) scores after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13) |
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Secondary Outcome(s) 6 | ||
Outcome | Change of EuroQol (EQ-5D) scores |
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Timepoint | Changes in EuroQol (EQ-5D) scores after V4, V8, V12 arbitration and 4 months after the end of arbitration(V13) |
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Secondary Outcome(s) 7 | ||
Outcome | Cost-benefit analysis and cost-effectiveness analysis between the two groups. |
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Timepoint | Every visit from visit 1 to visit 12 and 4 weeks after end of arbitration |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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