CTRI/2018/02/011841已完成2 期
Randomised, Double-Blind, Cross-Over Study Comparing theEfficacy and Safety of the Combination of Amitriptyline plusPregabalin vs. Amitriptyline alone in Painful Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
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
- •1)Presence of type 2 diabetes mellitus
- •2)No change in anti-diabetic medication for the past 1 month
- •3)Evidence of painful diabetic neuropathy by:
- •i.Diabetic Neuropathy Symptom Score >1 point
- •ii.Diabetic Neuropathy Examination Score >4
- •iii.Vibration perception test and monofilament
- •iv.Neuropathic pain present for at least 1
- •v.Mean pain intensity of more than 50% by patient
- •assessment by Visual Analog Scale (VAS)
排除标准
- •1)Age below 18 or above 75 years
- •2)Evidence of renal disease (S. creatinine > 1.5mg/dl)
- •3)Evidence of liver disease (AST and ALT 3 times upper normal limit
- •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
- •treatment, peripheral vascular disease and substance abuse.
- •7)Intake of anticonvulsants, antidepressants, membrane stabilizers
- •and opioids.
- •8)Participation in any other clinical trial in the past 30 days
研究者
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