Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyunghee University Medical Center
• Collaborators: Daegu Korean Medicine Hospital of Daegu Haany University; DongGuk University; Kyung Hee University Hospital at Gangdong
• Treatments: Loxoprofen

Criteria

Inclusion Criteria:

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 detailedexplanation of clinical trials

Exclusion Criteria:

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