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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Research on the Efficacy and Safety of Bosinji on LBP and Radiculopathy by HIVD of L-spine; A Multicenter, Randomized, Controlled, Clinical Trial

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Drug: Bosinji
* Drug: Loxonine tab.
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Drug: Bosinji<br>* Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g<br>* Other names: Ucha-Shinki-Hwan;Procedure: Acupuncture<br>* Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints) Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints) Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)<br>|
| Active Comparator: Control Group<br>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. | Drug: Loxonine tab.<br>* Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)<br>* Other names: Loxoprofen;Procedure: Acupuncture<br>* Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints) Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints) Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy, Bosinji, Herbal Medicine