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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Drug: Bosinji; Procedure: Acupuncture; Drug: Loxonine tab.

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42158
    • Daegu Korean Medicine Hospital of Daegu Haany University
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 02447
    • Kyunghee University Medical Center
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 13601
      • Dongguk University Bundang Oriental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; 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; Other Names: Ucha-Shinki-Hwan; Procedure: Acupuncture; 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)
Active Comparator: Control Group; 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.	Procedure: Acupuncture; 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); Drug: Loxonine tab.; Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg); Other Names: Loxoprofen

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Kyung Hee University Hospital at Gangdong; DongGuk University; Daegu Korean Medicine Hospital of Daegu Haany University
• Investigators: Principal Investigator: Byung-Kwan Seo, PhD., KMD, Kyunghee University Medical Center

Publications and helpful links

General Publications

• Goo B, Kim SJ, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial. Medicine (Baltimore). 2018 Dec;97(50):e13684. doi: 10.1097/MD.0000000000013684.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2017
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Low Back Pain; Herbal Medicine; Radiculopathy; Herniated Intervertebral Disc of Lumbar Spine; Bosinji
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: KHNMCOH 2017-08-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No