Health Condition 1: null- Acute Non Specific Low Back Pain
Conditions
Interventions
Intervention1: Fixed Dose Combination of Tolperisone HCl SR + Diclofenac Sodium SR: Fixed Dose Combination of Tolperisone HCl SR 450 mg + Diclofenac Sodium SR 100mg OD for seven days
Control Intervent
Sponsors
Inventia Health care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Non specific low back pain with an acute episode of recent onset (48 hours) defined by average pain within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS) Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain Willing to give written informed consent
Exclusion criteria
Exclusion criteria: Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorder., Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain. History of inflammatory arthritis of large joints. History of seizure disorders. History of malignant tumor. Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids. Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission. Psychiatric or mental diseases. Immune Compromised HIV. Inclusion in another study in the past six months or previous inclusion in this study. History of alcohol, drugs or narcotics abuse. Recent history of violent trauma. Constant progressive, non mechanical pain (no relief with bed rest). Thoracic pain. Patient systemically unwell. Unexplained weight loss. Widespread neurological symptoms (including Cauda equine syndrome). Structural deformity. Fever. Clinical significant renal dysfunction defined by Creatinine 1.5µmol/L. Clinically significant hepatic dysfunction defined by: Total Bilirubin 2 µmol/L. SGOT (AST) 1.5 U/L. SGPT (ALT) 1.5 U/L. Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy.) within the last 48 hours. Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the superiority of the SR of fixed - combination of a muscle relaxant, Tolperisone Hcl 450mg and non steroidal anti-inflammatory drug, Diclofenac sodium 100mg, over oral Tolperisone Hcl 150mg tablet as single drug therapy, on average pain and mobility within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset.Timepoint: DAY -1 DAY 1 DAY 4 DAY 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety of the oral FDC of Tolperisone Hcl + Diclofenac Sodium, to that of Tolperisone Hcl.Timepoint: DAY -1 DAY 1 DAY 4 DAY 7 | — |
Countries
India
Contacts
Public ContactGautam Saranath
NEXUS CLINICAL RESEARCH (INDIA) LTD.
Outcome results
None listed