Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
| DongGuk University | OTHER |
| Daegu Korean Medicine Hospital of Daegu Haany University | OTHER |
Not provided
Not provided
Not provided
Not provided
This randomized controlled clinical trial is designed to evaluate the efficacy and safety of Bosinji on low back pain and radiating pain of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.
Seventy-four patients between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the experimental group and the control group. In the experimental group, 2.5g of Bosinji granule (Tsumura & Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered in the same usage and period with the experimental group. In addition, both group will receive the same acupuncture treatment on 20 acupoints once a week for 6 weeks. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome at baseline and treatment end. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE), Deficiency Syndrome of Kidney Index (DSKI) will be measured as secondary outcomes at baseline, 3 weeks after screening, treatment end (6 weeks, primary endpoint) and follow-up sessions (10 weeks).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | In the experimental group, 2.5g of Bosinji granule (Tsmura Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week. |
|
| Control Group | Active Comparator | In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosinji | Drug | Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6 | Measurement instrument for subjective pain | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) |
| Measure | Description | Time Frame |
|---|---|---|
| 100mm Pain Visual Analogue Scale (VAS) for radiating pain | Measurement instrument for subjective pain | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) |
| Oswestry Disability Index (ODI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Byung-Kwan Seo, PhD., KMD | Kyunghee University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University Bundang Oriental Hospital | Seongnam-si | Gyeonggi-do | 13601 | South Korea | ||
| Daegu Korean Medicine Hospital of Daegu Haany University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39640075 | Derived | Goo B, Kim JH, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the effectiveness and safety of Uchasingihwan for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A multicenter, randomized, controlled equivalence trial. Integr Med Res. 2024 Dec;13(4):101090. doi: 10.1016/j.imr.2024.101090. Epub 2024 Sep 30. | |
| 30558079 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
Not provided
Not provided
| ID | Term |
|---|---|
| C040656 | loxoprofen |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Loxonine tab. | Drug | Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg) |
|
|
| Acupuncture | Procedure | Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes.
|
|
Validated questionnaire for disability of low back pain
| Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) |
| EuroQol-5 dimensions-5 level (EQ-5D-5L) | Standardized instrument for generic health status | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) |
| Roland-Morris Disability Questionnaire (RMDQ) | Health status measure for low back pain | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) |
| Global Perceived Effect (GPE) | Assessment of change in the patient's chief complaint | Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) |
| Deficiency Syndrome of Kidney Index (DSKI) | Questionnaire for assessing symptoms related to deficiency syndrome of kidney | Week 0 (Baseline), Week 6 (Primary end point, Treatment end) |
| Daegu |
| 42158 |
| South Korea |
| Kyunghee University Medical Center | Seoul | 02447 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Derived |
| Goo B, Kim SJ, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial. Medicine (Baltimore). 2018 Dec;97(50):e13684. doi: 10.1097/MD.0000000000013684. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |