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.

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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002939

Enrollment

200

Registered

2010-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Painful muscle spasms associated with musculoskeletal systems

Interventions

Intervention1: FDC Aceclofenac 200 mg and Thiocolchicoside 16 mg SR Tablet: 1 tablet once daily for maximum of 14 days, if patient is symptom free earlier than 14 days the medication can be stopped Co

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 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.

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 (number of episodes patient needed T. Paracetamol)Time needed for the patient to be symptom freeTimepoint: 0, 4 days, 7 days, 14 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, 14 days	—

Countries

India

Contacts

Public ContactDr Sumedh M Gaikwad

drmsatish@gmail.com9869055473

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026