CTRI/2010/091/000127已完成3 期
A prospective, controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Fixed Dose Combination of Tolperisone 150 mg and Paracetamol 500 mg in patients suffering from acute muscle spasms
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Pain intensity, tenderness, Joint mobility, Spasm relief, Need for rescue medication, Time needed for the patient to be symptom free
研究概览
简要总结
A prospective, controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Fixed Dose Combination of Tolperisone 150 mg and Paracetamol 500 mg in patients suffering from acute muscle spasms. (200 PATIENTS ENROLLED)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group between 18 to 70 years.
- •Patients presenting with moderate to severe painful muscle spasms and contractions associated with cervical and lumbar spondylosis, rheumatoid arthritis, osteoarthritis, blunt superficial trauma, low back pain.
- •Subjects who provide a written informed consent to abide by the study requirements.
排除标准
- •Patients with acute muscle spasms who need parenteral therapy / surgery / hospital admission for management.
- •Patients treated with any other oral / parenteral muscle relaxants, analgesics (NSAIDS & OPIOIDS) within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period.
- •Patients suffering from organic neurological disorders (Upper motor neuron disorders, cerebral palsy, pyramid tract injury, multiple sclerosis, cerebrovascular events, myelopathy, encephalomyelitis, etc), peripheral vascular diseases (arteriosclerosis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent), Little's disease and other encephalopathies accompanied by dystonia.
- •Patients suffering from myasthenia gravis or myopathies with muscle weakness as the prominent symptom.
- •Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
- •Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Pregnant and lactating females.
- •Simultaneous participation in another clinical study.
结局指标
主要结局
Pain intensity, tenderness, Joint mobility, Spasm relief, Need for rescue medication, Time needed for the patient to be symptom free
时间窗: 0, 4 days, 7 days, 14 days, 21 days
次要结局
- Digit / alphabet cancellation test, Reaction time :auditory and visual using the reaction time apparatus, Flicker fusion frequency using the flicker fusion apparatus, Measurement of hand grip strength, ADR recording, blood investigations(0, 21 days.)
研究者
研究点 (3)
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