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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bosinji
Loxonine tab.
Acupuncture
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy, Bosinji, Herbal Medicine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongguk University Bundang Oriental Hospital
  • Daegu Korean Medicine Hospital of Daegu Haany University
  • Kyunghee University Medical Center
  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6
Measurement instrument for subjective pain

Secondary Outcome Measures

100mm Pain Visual Analogue Scale (VAS) for radiating pain
Measurement instrument for subjective pain
Oswestry Disability Index (ODI)
Validated questionnaire for disability of low back pain
EuroQol-5 dimensions-5 level (EQ-5D-5L)
Standardized instrument for generic health status
Roland-Morris Disability Questionnaire (RMDQ)
Health status measure for low back pain
Global Perceived Effect (GPE)
Assessment of change in the patient's chief complaint
Deficiency Syndrome of Kidney Index (DSKI)
Questionnaire for assessing symptoms related to deficiency syndrome of kidney

Full Information

First Posted
December 21, 2017
Last Updated
February 3, 2020
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, DongGuk University, Daegu Korean Medicine Hospital of Daegu Haany University
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1. Study Identification

Unique Protocol Identification Number
NCT03386149
Brief Title
Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine
Official Title
Clinical Research on the Efficacy and Safety of Bosinji on LBP and Radiculopathy by HIVD of L-spine; A Multicenter, Randomized, Controlled, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, DongGuk University, Daegu Korean Medicine Hospital of Daegu Haany University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy, Bosinji, Herbal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bosinji
Other Intervention Name(s)
Ucha-Shinki-Hwan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Loxonine tab.
Other Intervention Name(s)
Loxoprofen
Intervention Description
Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6
Description
Measurement instrument for subjective pain
Time Frame
Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Secondary Outcome Measure Information:
Title
100mm Pain Visual Analogue Scale (VAS) for radiating pain
Description
Measurement instrument for subjective pain
Time Frame
Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Title
Oswestry Disability Index (ODI)
Description
Validated questionnaire for disability of low back pain
Time Frame
Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Title
EuroQol-5 dimensions-5 level (EQ-5D-5L)
Description
Standardized instrument for generic health status
Time Frame
Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Title
Roland-Morris Disability Questionnaire (RMDQ)
Description
Health status measure for low back pain
Time Frame
Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Title
Global Perceived Effect (GPE)
Description
Assessment of change in the patient's chief complaint
Time Frame
Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Title
Deficiency Syndrome of Kidney Index (DSKI)
Description
Questionnaire for assessing symptoms related to deficiency syndrome of kidney
Time Frame
Week 0 (Baseline), Week 6 (Primary end point, Treatment end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Kwan Seo, PhD., KMD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University Bundang Oriental Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13601
Country
Korea, Republic of
Facility Name
Daegu Korean Medicine Hospital of Daegu Haany University
City
Daegu
ZIP/Postal Code
42158
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30558079
Citation
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.
Results Reference
derived

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

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