NCT03386149

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

Clinical Research on the Efficacy and Safety of Bosinji on LBP and Radiculopathy by HIVD of L-spine; A Multicenter, Randomized, Controlled, Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
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
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)

Timeline

• Start date: 2017-12-28
• Primary completion: 2019-12-27
• Completion: 2020-01-22
• First posted: 2017-12-29
• Last updated: 2020-02-05

Locations

4 sites across 1 country: South Korea