A RANDOMIZED COMPARATIVE STUDY EVALUATINGTHE EFFICACY OF PREGABALIN AND DULOXETINEVersus PREGABALIN AND NORTRIPTYLINE AND THEMODULATION OF mRNA EXPRESSION OF HLA-A33 ANDHLA-B44 GENES IN PATIENTS OF POST-HERPETIC NEURALGIA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving NRS-pain score of 4/10 at the end of 12th week in both
研究概览
简要总结
The present randomized comparative study evaluating the efficacy of pregabalin and duloxetine versus Pregabalin and Nortriptyline and the modulation of mRNA expression of HLA-A33 and HLA-B44 genes in the management of post-herpetic neuralgia.Patients with diagnosis of PHN with evident hyperalgesia and allodynia or patients of PHN having pain for at least 12 weeks after the healing of rash or Pain intensity ≥ 4 on 10 of NRS-pain scale will be included.Patients will be excluded if there is history of neurological intervention for PHN or evidence of other sources of chronic or acute pain that may confound the diagnosis or Known history of intake Pregabalin or Duloxetine for PHN in past 4 weeks or past h/o MI, DM, pancreatitis and vasculitis or any evidence of renal impairment/history of alcohol consumption and smoking or psychiatric or substance abuse disorder.Patients suffering from PHN will be divided into two groups of twenty-five patients each by random allocation. One group will receive combination of Pregabalin plus Duloxetine and other group Pregabalin and Nortriptyline. Assessment of pain will be done at baseline and at the end of 1st week,2nd week,4th week,8th week and 12th week.The sample size for the study will be 25 patients in each group.Primary outcome measure is NRS-pain score.
Secondary outcome measures are NPSI, NRS-sleep score,PDQ score ,quality of life (QoL) using SF-12 score. Modulation in mRNA expressions of HLA-A33 and HLA-B44 genes at baseline and after 12 weeks of treatment.
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
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients should have a diagnosis of PHN with evident hyperalgesia and allodynia.
- •3.Pain intensity ≥ 4 on 10 of NRS-pain scale.
排除标准
- •1.Patients with history of neurological intervention for PHN.
- •2.Evidence of other sources of chronic or acute pain that may confound the diagnosis
- •Known history of intake Pregabalin or Duloxetine for PHN in past 4 weeks.
- •Patients with past h/o MI, DM, pancreatitis and vasculitis.
- •Patients with evidence of renal impairment/history of alcohol consumption and smoking.
- •6.Patients with psychiatric or substance abuse disorder.
结局指标
主要结局
Proportion of patients achieving NRS-pain score of 4/10 at the end of 12th week in both
时间窗: At baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week.
the groups.
时间窗: At baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week.
2. The neuropathic component of pain using NPSI score in both the groups.
时间窗: At baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week.
次要结局
- 1. NRS-sleep score in the two groups at various designated intervals.(2. PDQ score in both the groups at various designated intervals.)