A randomised, two arm, openlabel, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical fixed dose combination of a muscle relaxant Thiocolchicoside and a non steroidal anti-inflammatory drug, Diclofenac in comparison with Diclofenac Topical gel ( 1.16% w/w) in acute non-specific low back pain.

Troikaa Pharmaceuticals Ltd0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

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•1. Male of Female patients aged 18-60 years
•2. Non specific low back pain with an acute episode of recent onset(less than 48 hours) defined by average pain within the last 24 hours equal or more than 5 on the Visual Analogue Scale (VAS)
•3. Low back pain of diagnostic 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
•4. Patients who are willing to take medications as directed, to come for follow ups, to give written consent and comply with the protocol requirements.

•1. 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 disorders.
•2. Low back pain of diagnostic 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.
•3. History of Inflammatory arthritis of Large Joints, or any structural deformity.
•4. History of seizure disorder, or any recent history of violent trauma, psychiatric or mental diseases or any widespread neurological symptoms.
•5. History of malignant tumor.
•6. Patient who have received other therapy [NSAIDs( including aspirin), muscle relaxant or opioid analgesics, physiotherapy, physical manipulations, invasive intervention, accupuncture therapy] within last 48 hours.
•7. History of Immunosuppression, HIV or use of immunosuppressive drugs.
•8. Inclusion in another study in past 6 months or previous inclusion in this study.
•9. History of alcohol, drug or narcotics abuse.
•10. Constant progressive, non mechanical pain(no relief with bed rest)
•11. Thoracic pain
•12. Patient systemically unwell or having fever, or unexplained weight loss.
•13. Clinically significant renal dysfunction/ hepatic dysfunction.

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