CTRI/2011/11/002116
已完成
3 期
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.
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Troikaa Pharmaceuticals Ltd
- 入组人数
- 150
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
未指定
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