Status:
COMPLETED
Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine
Lead Sponsor:
Kyunghee University Medical Center
Collaborating Sponsors:
Kyung Hee University Hospital at Gangdong
DongGuk University
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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 p...
Detailed Description
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 gr...
Eligibility Criteria
Inclusion
- Men or women aged over 19 years
- Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
- low back pain between 40 and 80 point on 100mm pain visual analogue scale
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailedexplanation of clinical trials
Exclusion
- Congenital abnormalities or surgical history on lumbar regions
- Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
- Tumor, fracture or infection in lumbar regions
- Injection treatment on lumbar regions within 1 week
- Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
- Liver function abnormality (AST or ALT over 2times normal range)
- Renal fuction abnormaility (Serum creatinine \> 2.0㎎/㎗)
- 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
- Contraindication of NSAIDs including intercurrent disease, hypersensitivity reaction or other medication
- Inappropriate condition for acupuncture due to skin disease or hemostatic disorder (PT INR \> 2.0 or taking anticoagulant)
- Women who is pregnant, breastfeeding or having pregnancy plan
- Other inappropriate condition for herbal medicine treatment
- participation in other clinical trial with 1 month
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03386149
Start Date
December 28 2017
End Date
January 22 2020
Last Update
February 5 2020
Active Locations (4)
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1
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13601
2
Daegu Korean Medicine Hospital of Daegu Haany University
Daegu, South Korea, 42158
3
Kyunghee University Medical Center
Seoul, South Korea, 02447
4
Kyung Hee University Hospital at Gangdong
Seoul, South Korea, 05278