Clinical research on the efficacy and safety of Bosinji on low back pain and radiculopathy by herniated intervertebral disc of lumbar spine; A multicenter, randomized, controlled, clinical trial

Kyung Hee University0 个研究点目标入组 74 人开始时间: 待定最近更新: 2020年2月24日

适应症

试验速览

暂无简介。

•1. Men or women aged over 19 years
•2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
•3. low back pain between 40 and 80 point on 100mm pain visual analogue scale
•4. Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials

•1. Congenital abnormalities or surgical history on lumbar regions
•2. Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
•3. Tumor, fracture or infection in lumbar regions
•4. Injection treatment on lumbar regions within 1 week
•5. Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
•6. Liver function abnormality (AST or ALT over 2times normal range)
•7. Renal fuction abnormaility (Serum creatinine > 2.0?/?)
•8. Other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
•9. Contraindication of NSAIDs including intercurrent disease, hypersensitivity reaction or other medication
•10. Inappropriate condition for acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
•11. Women who is pregnant, breastfeeding or having pregnancy plan
•12. Other inappropriate condition for herbal medicine treatment
•13. participation in other clinical trial with 1 month

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