A clinical trial to study the effects of Eperisone SR in patients suffering from acute muscle spasms.

A prospective, active-controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Eperisone SR (150 mg)in patients suffering from acute muscle spasms.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000077

Enrollment

200

Registered

2010-03-12

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- Acute Muscle Spasms

Interventions

Intervention1: Eperisone: Sustained Release (150 mg - once a day for maximum of 10 days) Control Intervention1: Eperisone: Immediate Release (50 mg - 3 times a day for maximum of 10 days)

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, tenderness, Joint mobility, Spasm relief, Need for rescue medication, Time needed for the patient to be symptom freeTimepoint: 0, 3 days, 7 days, 10 days	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Sumedh M Gaikwad

argekar@gmail.com09820654780

Outcome results

None listed

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