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

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386149
• Other study ID #: KHNMCOH 2017-08-002
• Status: Completed
• Phase: Phase 3
• Start date: December 28, 2017
• Est. completion date: January 22, 2020

Study information

• Verified date: February 2020
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 22, 2020
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation
• Radiculopathy

Intervention

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
• 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. 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)

Locations

Country	Name	City	State
Korea, Republic of	Daegu Korean Medicine Hospital of Daegu Haany University	Daegu
Korea, Republic of	Dongguk University Bundang Oriental Hospital	Seongnam	Gyeonggi
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Daegu Korean Medicine Hospital of Daegu Haany University, DongGuk University, Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)