Health Condition 1: null- Acute Muscle Spasms
Conditions
Interventions
Intervention1: FDC of Tolperisone 150 mg + Diclofenac 50 mg Tablet: Fixed Dose Combination Tablet ----- Thrice daily for maximum period of 21 days
Control Intervention1: Diclofenac Sodium 50 mg Tablet
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Patients with acute muscle spasms 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity (recorded on VAS), tenderness (graded from 0 to 3), joint mobility (recorded on VAS), Spasm relief (recorded on VAS), need for rescue medication. Time needed for the patient to be symptom free.Timepoint: 0, 4 days, 7 days, 14 days, 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 investigationsTimepoint: 0, 21 days | — |
Countries
India
Contacts
Public ContactDr Sumedh M Gaikwad
Outcome results
None listed