Health Condition 1: null- Acute Muscle Spasms
Conditions
Interventions
Intervention1: FDC OF TOLPERISONE + PARACETAMOL TABLETS: TOLPERISONE 150 MG + PARACETAMOL 500 MG (FDC), WITH PLACEBO TABLET THRICE DAILY FOR 21 DAYS
Control Intervention1: TABLET TIZANIDINE AND 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 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. 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) within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period. 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, 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. 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, tenderness, Joint mobility, Spasm relief, Need for rescue medication, Time needed for the patient to be symptom freeTimepoint: 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