drugset / Trial / NCT03386149
Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine
Phase 3
Completed
74 enrolled
Kyunghee University Medical Center
Daegu Korean Medicine Hospital of Daegu Haany University · collabDongGuk University · collabKyung Hee University Hospital at Gangdong · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2017-12-28
- Primary completion
- 2019-12-27
- Completion
- 2020-01-22
Outcome
Met primary endpoint
paper at weeks 6 (95 % CI:9.26, 8.37) and 10 (95 % CI:9.03, 9.62) from baseline were within the equivalence limit. PMID 39640075 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bosinji | Traditional medicine (herbal / TCM) | 2.5 g | Oral |
| Comparator | Loxoprofen | Small molecule | 60 mg | Oral |