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

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ClinicalTrials.gov Identifier: NCT03386149
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Kyung Hee University Hospital at Gangdong
DongGuk University
Daegu Korean Medicine Hospital of Daegu Haany University
Information provided by (Responsible Party):
Byung-Kwan Seo, 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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Drug: Bosinji Drug: Loxonine tab. Procedure: Acupuncture Phase 3

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  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : September 30, 2018

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 Name: 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.

  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)

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

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.

  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)




Primary Outcome Measures :
  1. Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6 [ Time Frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) ]
    Measurement instrument for subjective pain


Secondary Outcome Measures :
  1. 100mm Pain Visual Analogue Scale (VAS) for radiating pain [ Time Frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) ]
    Measurement instrument for subjective pain

  2. Oswestry Disability Index (ODI) [ Time Frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) ]
    Validated questionnaire for disability of low back pain

  3. EuroQol-5 dimensions-5 level (EQ-5D-5L) [ Time Frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) ]
    Standardized instrument for generic health status

  4. Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) ]
    Health status measure for low back pain

  5. Global Perceived Effect (GPE) [ Time Frame: Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) ]
    Assessment of change in the patient's chief complaint

  6. Deficiency Syndrome of Kidney Index (DSKI) [ Time Frame: Week 0 (Baseline), Week 6 (Primary end point, Treatment end) ]
    Questionnaire for assessing symptoms related to deficiency syndrome of kidney



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386149


Contacts
Contact: Bonhyuk Goo, M.S., KMD +821077959940 goobh99@naver.com
Contact: Sungjin Kim, M.S., KMD +821073398810 ksj900716@naver.com

Locations
Korea, Republic of
Dongguk University Bundang Oriental Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 13601
Contact: Eun-Jung Kim, PhD., KMD    +82317103751    hanijjung@naver.com   
Daegu Korean Medicine Hospital of Daegu Haany University Recruiting
Daegu, Korea, Republic of, 42158
Contact: I-Rang Choi, B.S    +82537702324    soongood88@dhu.ac.kr   
Kyunghee University Medical Center Recruiting
Seoul, Korea, Republic of, 02447
Contact: Sae-Rom Jeon, B.S.    +821050478756    sr9213@naver.com   
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Contact: Bonhyuk Goo, M.S., KMD    +8224406099    goobh99@naver.com   
Sponsors and Collaborators
Kyunghee University Medical Center
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

Responsible Party: Byung-Kwan Seo, Principal Investigator, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT03386149     History of Changes
Other Study ID Numbers: KHNMCOH 2017-08-002
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Byung-Kwan Seo, Kyunghee University Medical Center:
Herniated Intervertebral Disc of Lumbar Spine
Low Back Pain
Radiculopathy
Bosinji
Herbal Medicine

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases