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

Phase 3

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Drug: Bosinji; Drug: Loxonine tab.; Procedure: Acupuncture

• Registration Number: NCT03386149
• Lead Sponsor: Kyunghee University Medical Center

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 pain, function, and quality of life.

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 group, 2.5g of Bosinji granule (Tsumura \& Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered in the same usage and period with the experimental group. In addition, both group will receive the same acupuncture treatment on 20 acupoints once a week for 6 weeks. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome at baseline and treatment end. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE), Deficiency Syndrome of Kidney Index (DSKI) will be measured as secondary outcomes at baseline, 3 weeks after screening, treatment end (6 weeks, primary endpoint) and follow-up sessions (10 weeks).

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Study Start: 2017-12-28
• Study First Posted: 2017-12-29
• Primary Completion: 2019-12-27
• Study Completion: 2020-01-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Acupuncture	In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week.
Experimental Group	Bosinji	In the experimental group, 2.5g of Bosinji granule (Tsmura Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week.
Experimental Group	Acupuncture	In the experimental group, 2.5g of Bosinji granule (Tsmura Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week.
Control Group	Loxonine tab.	In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week.

Primary Outcome Measures

Name	Time	Method
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6	Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)	Measurement instrument for subjective pain

Secondary Outcome Measures

Name	Time	Method
EuroQol-5 dimensions-5 level (EQ-5D-5L)	Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)	Standardized instrument for generic health status
Global Perceived Effect (GPE)	Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)	Assessment of change in the patient's chief complaint
Oswestry Disability Index (ODI)	Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)	Validated questionnaire for disability of low back pain
100mm Pain Visual Analogue Scale (VAS) for radiating pain	Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)	Measurement instrument for subjective pain
Roland-Morris Disability Questionnaire (RMDQ)	Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)	Health status measure for low back pain
Deficiency Syndrome of Kidney Index (DSKI)	Week 0 (Baseline), Week 6 (Primary end point, Treatment end)	Questionnaire for assessing symptoms related to deficiency syndrome of kidney

Trial Locations

Locations (4)

Dongguk University Bundang Oriental Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of

Daegu Korean Medicine Hospital of Daegu Haany University; 🇰🇷 Daegu, Korea, Republic of

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of