Health Condition 1: null- Pain associated with Skeletal Muscular Spasm of any Etiology
Conditions
Interventions
Intervention1: FDC of Lornoxicam + Thiocolchicoside Tablet: Fixed Dose Combination of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet Once a day orally for 7 days.
Control Intervention1: Thiocol
Sponsors
Inventia Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Non specific skeletal muscular spasm, with an acute episode. Recent onset ( Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Acute pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders. 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 ( Annexure â??V) 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 > 1.5 mg/dl Clinically significant hepatic dysfunction defined by: Total Bilirubin > 2 mg/dl SGOT (AST) > 1.5 IU/L SGPT (ALT) > 1.5 IU/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. Known or suspected hypersensitivity to Thiocolchicoside and Lornoxicam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 4 in both treatment groups.Timepoint: At day 4 of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at day 7 i.e. completion of protocol treatment in both treatment groups.Timepoint: At day 7 of the treatment | — |
Countries
India
Contacts
Public ContactMr Gangadhar Hulsure
NEXUS CLINICAL RESEARCH (INDIA) LTD.
Outcome results
None listed