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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
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
Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)
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)
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, South Korea
Daegu Korean Medicine Hospital of Daegu Haany University
Daegu, South Korea
Kyunghee University Medical Center
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6
Measurement instrument for subjective pain
Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
100mm Pain Visual Analogue Scale (VAS) for radiating pain
Measurement instrument for subjective pain
Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Oswestry Disability Index (ODI)
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)
EuroQol-5 dimensions-5 level (EQ-5D-5L)
Standardized instrument for generic health status
Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Roland-Morris Disability Questionnaire (RMDQ)
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)
Global Perceived Effect (GPE)
Assessment of change in the patient's chief complaint
Time frame: Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Deficiency Syndrome of Kidney Index (DSKI)
Questionnaire for assessing symptoms related to deficiency syndrome of kidney
Time frame: Week 0 (Baseline), Week 6 (Primary end point, Treatment end)
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