Clinical Research on the Efficacy of Bosinji on Low Back Pain and Radiculopathy by Herniated Intervertebral Disc of Lumbar Spine

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002848

Enrollment

Registered

2018-05-04

Start date

2017-12-28

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In the experimental group, 2.5g of Bosinji granule will be orally administered three times a day at 30 minutes after the meal for 6 weeks. In the control group, Loxonine tab. (60mg) will be ora

Eligibility

Sex/Gender

All

Inclusion 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 detailed explanation of clinical trials

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
100mm Pain Visual Analogue Scale (VAS) for low back pain	—

Secondary

Measure	Time frame
Deficiency Syndrome of Kidney Index (DSKI);100mm Pain Visual Analogue Scale (VAS) for radiating pain;Oswestry Disability Index (ODI);EuroQol-5 dimensions-5 level (EQ-5D-5L);Roland-Morris Disability Questionnaire (RMDQ);Global Perceived Effect (GPE)	—

Countries

Korea, Republic of

Contacts

Public ContactBonhyuk Goo

Kyung Hee University Oriental Medicine Hospital at Gangdong

Outcome results