A prospective,randomized, comparative study of safety and efficacy of pregabalin, duloxetine, amitriptyline and pregabalin plus amitriptyline in neuropathic pain in a tertiary care hospital in West Bengal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To find out the drug with maximum efficacy in reducing neuropathic pain,as measured by Neuropathic pain symptom Inventory score(NPSI)in a treatment group.
研究概览
简要总结
An open label, comparative, randomised, prospectivestudy will be conducted regarding the safety & efficacy ofPregabalin,Duloxetine,Amitryptiline &Pregabalin plus Amitryptiline onreducing neuropathic pain,due to various etiology,in patients of age group18-75 yrs, attending Neurology OPD B.S.Medical college.Total duration of studywill be one year(Feb 2015-Jan 2016).Patients will be followed up for 4 weeks..Wewill also assess the therapeutic safetyin each treatment groups and any associated adverse effects. Simultaneously wewill also assess the quality of improvement of sleep in each treatmentgroups.The key objectives will be to find out the drug with maximum efficacy inreducing neuropathic pain as well as in improving the quality of sleep in thepatients.We will also try to find out the drug with minimum adverse effects intheir respective study groups.The study will proceed after obtaining ethicalclearance from the institutional ethics committee. Before beginning theinterview, informed written consent will be taken from each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: (1)Diagnosed by consultant neurologist as having neuropathic pain.
- •(2)Scoring ≥4 at DN4 Neuropathic pain diagnostic questionnaire (3)Scoring ≥4 at Numeric pain rating scale at baseline presentation.
- •(4)Age group 18-75 yrs.
排除标准
- •Exclusion criteria: (1)Known serious spinal disease/bony deformity/vertebral fracture (2)Abnormal renal function test.
- •(3)Cardiac conduction defect.
- •(4)Known allergy to any of the study medication.
- •(5)Benign Hyperplasia of prostate or H/O urinary retention.
- •(6)Pregnant& lactating mother.
- •(7)Patients taking MAO inhibitors.
- •(8)Inflammatory/Rheumatologic disorder.
- •(9)Suicidal tendency.
结局指标
主要结局
To find out the drug with maximum efficacy in reducing neuropathic pain,as measured by Neuropathic pain symptom Inventory score(NPSI)in a treatment group.
时间窗: 4 weeks
次要结局
- To find out the drug which causes maximum improvement of Quality of sleep as measured by The Pittsburgh Sleep Quality Index (PSQI)score.(4 weeks)
- Comparison of incidence of adverse drug reaction in each treatment groups.