A prospective, controlled, randomized, open, comparative, parallel, 2 - arm study to evaluate the efficacy and safety of FDC tablet of Aceclofenac 200 mg and Thiocolchicoside 16 mg SR versus FDC tablet of Aceclofenac 100 mg and Thiocolchicoside 8 mg IR in patients suffering from painful muscle spasms associated with musculoskeletal systems.

Themis Medicare Limited Udyog Nagar S V Road Goregaon West Mumbai0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Patients of either sex in the age group between 18 to 70 years.
•2. Patients painful muscle spasms and contractions associated with cervical and lumbar spondylosis, rheumatoid arthritis, osteoarthritis, blunt superficial trauma, low back pain.
•3. Subjects who provide a written informed consent to abide by the study requirements.

•1. Patients with painful muscle spasms associated with musculoskeletal systems, who need parenteral therapy / surgery / hospital admission for management.
•2. Patients treated with any other oral / parenteral muscle relaxants, analgesics (NSAIDS & Opioids) medications within 1 week prior to the study.
•3. 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, diabetic angiopathy, thrombangiitis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent); Little's diseases and other encephalopathies accompanied by dystonia.
•4. Patients suffering from myasthenia gravis or myopathies with muscle weakness as the prominent symptom.
•5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
•6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
•7. Pregnant and lactating females.
•8. Simultaneous participation in another clinical study.

发起方

Themis Medicare Limited Udyog Nagar S V Road Goregaon West Mumbai