CTRI/2024/12/078069尚未招募4 期
Efficacy & Safety of Mirtazapine in Diabetic Patient with Pruritus: A Randomized Controlled Study
All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月24日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- to compare the efficacy of mirtazapine in pruritus among diabetic patients to standard care group measured by 50 % reduction in visual analogue scale for pruritus after 12 weeks of therapy from baseline.
研究概览
简要总结
mirtazapine, an antidepressant with both noradrenergic and serotonergic properties have shown promise in alleviating itch severity. as a blocker of H1,5HT2,5HT3 receptors it may serve as an alternative treatment for pruritus that does not respond to first line therapy. mirtazapine is thought to reduce itch centrally by antagonizing alfa 2 adrenergic receptors.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •patient of either sex and age more than 18 years.
- •2.persistant pruritus for 6 weeks or more.
- •3.patient diagnosed with diabetic pruritus and having HbA1cmore than 7.5.
排除标准
- •Patients with AST and ALT three times above the normal level.
- •Creatinine clearance (CrCl) less than 30 ml/min/1.73m2 .
- •Patients with pruritus of known dermatological causes such as liver disease, Psoriasis, Lichen planus, Scabies, etc.
- •Pregnant and lactating women.
- •Patients taking opioids for therapeutic purpose.
- •History of allergy / hypersensitivity to Mirtazapine.
- •7.Patient already receiving pregabalin, gabapentin or other therapy.
- •8.Use of Monoamine oxidase inhibitors (MAO inhibitors).
结局指标
主要结局
to compare the efficacy of mirtazapine in pruritus among diabetic patients to standard care group measured by 50 % reduction in visual analogue scale for pruritus after 12 weeks of therapy from baseline.
时间窗: 4,8,12 week
次要结局
- 1.to evaluate the efficacy of mirtazapine in pruritus among diabetic patients using 5D pruritus scale from baseline(4,8,12 week)
- 2.to evaluate change in dermatology life quality index from baseline.(4,8,12 week)
- 3.to evaluate change in quality of sleep using epworth sleepiness scale from baseline(4,8,12 week)
- 4.to evaluate change in anxiety score using hamilton anxiety rating scale from baseline.(4,8,12 week)
- 5.to evaluate safety (hba1c & FBS) and any adverse effect of mirtazapine(4,8,12 week)
研究者
Dr Sneha Ambwani
AIIMS Jodhpur
研究点 (1)
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