Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Non-specific Chronic Low Back Pain of Lumbosacral Localization in Ambulatory Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.
详细描述
We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-65 years, inclusively.
- •Pain intensity according to Visual Analogue Scale (VAS) > 3 points.
- •Duration of back pain > 12 weeks.
- •Pain reinforcement during movement in lumbar spine.
- •Osteoarthritis, spondylarthrosis, osteochondrosis.
- •Given written Informed consent form for participation in the study.
- •Treatment with ARTRA
排除标准
- •History of allergic reactions to chondroprotectors.
- •Participation in another clinical study within 30 days before screening or during this study.
- •Fibromyalgia.
- •Active neoplastic disease, history of neoplastic disease within 3 years before screening.
- •Paget's disease.
- •Degenerative spondylolisthesis.
- •Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle relaxant drugs for more than one week prior screening.
- •History of alcohol or drug abuse.
- •Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face and extremities edema, dizziness and headache.
- •History of any disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject during participation in the study
- •Clinically significant renal disorders.
结局指标
主要结局
Pain Intensity
时间窗: 3 months
Pain intensity on Visual Analogue Scale
次要结局
- Oswestry Disability Index(3 months)
- Patient global assessment of efficacy(3 months)
- NSAID consumption(3 months)