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

NCT03386149 | Completed Phase 3

• 1 other identifier: KHNMCOH 2017-08-002
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

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.

Conditions

Lumbar Disc Herniation

Keywords

Herniated Intervertebral Disc of Lumbar Spine; Low Back Pain; Radiculopathy; Bosinji; Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• Oswestry Disability Index (ODI)

  Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

• EuroQol-5 dimensions-5 level (EQ-5D-5L)

  Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

• Roland-Morris Disability Questionnaire (RMDQ)

  Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

• Global Perceived Effect (GPE)

  Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Procedure: Acupuncture

Control Group

ACTIVE COMPARATOR

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.; Procedure: Acupuncture

Interventions

Bosinji DRUG

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

Also known as: Ucha-Shinki-Hwan

Experimental Group

Loxonine tab. DRUG

Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)

Also known as: Loxoprofen

Control Group

Acupuncture PROCEDURE

Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes. 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints) 2. Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints) 3. Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)

Control Group; Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• Kyung Hee University Hospital at Gangdong: collaborator
• DongGuk University: collaborator
• Daegu Korean Medicine Hospital of Daegu Haany University: collaborator

Study Sites (4)

Dongguk University Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, 13601, South Korea

Location

Daegu Korean Medicine Hospital of Daegu Haany University

Daegu, 42158, South Korea

Location

Kyunghee University Medical Center

Seoul, 02447, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Related Publications (2)

• Goo B, Kim JH, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the effectiveness and safety of Uchasingihwan for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A multicenter, randomized, controlled equivalence trial. Integr Med Res. 2024 Dec;13(4):101090. doi: 10.1016/j.imr.2024.101090. Epub 2024 Sep 30.

  PMID: 39640075 DERIVED

• 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.

  PMID: 30558079 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain; Radiculopathy

Interventions

loxoprofen; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Byung-Kwan Seo, PhD., KMD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: December 28, 2017
• Primary Completion: December 27, 2019
• Study Completion: January 22, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

KR (4)