Clinical Research on the Efficacy and Safety of Bosinji on LBP and Radiculopathy by HIVD of L-spine; A Multicenter, Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged over 19 years
- •Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
- •low back pain between 40 and 80 point on 100mm pain visual analogue scale
- •Volunteers who agree to participate and sign the Informed Consent Form, following a detailedexplanation of clinical trials
排除标准
- •Congenital abnormalities or surgical history on lumbar regions
- •Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
- •Tumor, fracture or infection in lumbar regions
- •Injection treatment on lumbar regions within 1 week
- •Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
- •Liver function abnormality (AST or ALT over 2times normal range)
- •Renal fuction abnormaility (Serum creatinine > 2.0㎎/㎗)
- •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
- •Contraindication of NSAIDs including intercurrent disease, hypersensitivity reaction or other medication
- •Inappropriate condition for acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
- •Women who is pregnant, breastfeeding or having pregnancy plan
- •Other inappropriate condition for herbal medicine treatment
- •participation in other clinical trial with 1 month
研究组 & 干预措施
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.
干预措施: Bosinji (Drug)
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.
干预措施: Acupuncture (Procedure)
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.
干预措施: Loxonine tab. (Drug)
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.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6
时间窗: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Measurement instrument for subjective pain
次要结局
- EuroQol-5 dimensions-5 level (EQ-5D-5L)(Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U))
- Global Perceived Effect (GPE)(Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U))
- Oswestry Disability Index (ODI)(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(Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U))
- Roland-Morris Disability Questionnaire (RMDQ)(Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U))
- Deficiency Syndrome of Kidney Index (DSKI)(Week 0 (Baseline), Week 6 (Primary end point, Treatment end))
研究者
Byung-Kwan Seo
Principal Investigator
Kyunghee University Medical Center