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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-28

Study Completion Date

2020-01-22

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Bosinji

Intervention Type 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

Acupuncture

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Loxonine tab.

Intervention Type DRUG

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

Acupuncture

Intervention Type 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)

Interventions

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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

Intervention Type DRUG

Loxonine tab.

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

Intervention Type DRUG

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)

Intervention Type PROCEDURE

Other Intervention Names

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Ucha-Shinki-Hwan Loxoprofen

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No