A clinical study to evaluate the efficacy and safety of FDC of Tolperisone and Paracetamol in patients suffering from acute muscle spasms

Phase 3

Completed

• Conditions: Health Condition 1: null- Acute Muscle Spasms

• Registration Number: CTRI/2010/091/000127
• Lead Sponsor: Themis Medicare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified