A clinical trial to study the effects of two drugs, in fixed dose combination tablet - Aceclofenac and Thiocolchicoside Sustained Release in patients suffering from painful muscle spasms associated with musculoskeletal systems.

Phase 3

• Conditions: Painful muscle spasms associated with musculoskeletal systems

• Registration Number: CTRI/2010/091/002939
• Lead Sponsor: Themis Medicare Limited Udyog Nagar S V Road Goregaon West Mumbai

Brief Summary

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 verus FDC tablet of Aceclofenac 100 mg and Thiocolchicoside 8 mg IR in patients suffering from painful muscle spasms associated with musculoskeletal systems.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients of either sex in the age group between 18 to 70 years.
• Patients 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 (number of episodes patient needed T. Paracetamol)Time needed for the patient to be symptom free	0, 4 days, 7 days, 14 days

Secondary Outcome Measures

Name	Time	Method
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, 14 days

Trial Locations

Locations (3)

Ashirwad Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Dhule Hospital; 🇮🇳 Aurangabad, BIHAR, India

Rajawadi Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Ashirwad Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr. Satish Masavkar

Principal investigator

9869055473

drmsatish@gmail.com