CTRI/2025/10/095929尚未招募2 期
A study to compare the efficacy,safety and Quality of life in patients with Moderate Diabetic Peripheral Neuropathic Pain on Pregabalin versus Amitriptyline at a tertiary care centre-A Randomised Control Study
Dr Chethana1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年11月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Reduction in severity of Neuropathic pain assessed by NRS SCALE
研究概览
简要总结
Chronic pain in patients with diabetic peripheral neuropathy significantly affects physical functioning emotional well-being and overall quality of life Pregabalin and Amitriptyline are commonly used first-line agents for pain management This study could highlight evident variations in their impact on quality of life with Pregabalin and Amitriptyline conferring more substantial improvements in overall QoL particularly across the domains of energy sleep and emotional well-being
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with moderate diabetic neuropathic pain.
排除标准
- •pregnancy lactation hepatic dysfunction renal dysfunction arryhthmias.
结局指标
主要结局
Reduction in severity of Neuropathic pain assessed by NRS SCALE
时间窗: Reduction in severity of Neuropathic pain assessed by NRS SCALE IN 6 WEEKS
次要结局
- Improvement of quality of life index with pain reduction assessed by NEUROQOL SCORE(6 weeks)
研究者
Dr Chethana Amarnath
Banglore Medical College and Research Institute
研究点 (1)
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