CTRI/2010/091/001036已完成4 期
A randomized double blind Trial comparing Efficacy and Safety of Duloxetine vs. Amitriptyline in painful Diabetic Neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PGIMER
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria
- •1. Presence of type 2 diabetes mellitus
- •2. No change in anti-diabetic medication for the last 1 month
- •3. Evidence of diabetic neuropathy by Diabetic Neuropathy
- •Symptom Score >1 point, Diabetic Neuropathy Examination Score
- •>4 point, Vibration perception test and monofilament test.
- •4. Neuropathic pain present for at least 1 month
- •5. Mean pain intensity of more than 50% by patient assessment by
排除标准
- •Exclusion criteria
- •1. Age below 18 or above 75 years
- •2. Evidence of renal disease (Se. creatinine > 1.5)
- •3. Evidence of liver disease (deranged LFT with clinical evidence)
- •4. Pregnant and lactating mothers and women intending pregnancy
- •5. Evidence of other causes for neuropathy and painful conditions
- •6. Epilepsy, psychiatric and cardiac diseases, hypertensives not on
- •peripheral vascular disease and substance abuse.
- •7. Intake of anticonvulsants, antidepressants, membrane
- •stabilizers and opioids
- •8. Participation in any other clinical trial with in the last 30 days
研究者
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