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临床试验/CTRI/2026/04/107346
CTRI/2026/04/107346尚未招募不适用

Evaluation of Efficacy and Safety of Duloxetine, Amitriptyline, and Gabapentin for Diabetic Polyneuropathy patients: A Prospective Observational Study

Dr Radhika Lakhtariya1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
• Primary Outcomes:

研究概览

简要总结

This study will be a prospective, observational  study to evaluate the efficacy and safety of duloxetine, amitriptyline, and gabapentin in patients with diabetic polyneuropathy, conducted in the Departments of Pharmacology and Neurology at Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India. A total of 90 adult patients with clinically diagnosed diabetic polyneuropathy confirmed by nerve conduction study, newly prescribed duloxetine 30 mg once daily, amitriptyline 10 mg at bedtime, or gabapentin 300 mg once daily, will be included. Primary outcomes will include changes in pain severity assessed by Visual Analog Scale (VAS), burning sensation, anxiety symptoms, and sleep disturbance using Likert scales from baseline to 6 weeks, while secondary outcomes will include incidence of adverse effects such as sedation, dizziness, edema, urinary retention, and dry mouth. Comparative analysis among the three groups will help determine the most effective and safest treatment option for diabetic polyneuropathy patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1 Adults 18 years or more than 18 years with clinical diagnosis of diabetic polyneuropathy 2 willingness to provide informed consent and comply with study procedures.

排除标准

  • 1 Severe renal or hepatic impairment 2 Use of other neuropathic pain medications 3 History of substance abuse 4 Pregnancy or lactation 5 Hypersensitivity or allergy to study drugs (duloxetine, amitriptyline, and gabapentin).

结局指标

主要结局

• Primary Outcomes:

时间窗: from baseline to follow up after 6 weeks

o Change in Visual Analog Scale (VAS) for pain from baseline to 6 weeks

时间窗: from baseline to follow up after 6 weeks

o Change in burning sensation severity from baseline to 6 weeks

时间窗: from baseline to follow up after 6 weeks

o Change in anxiety from baseline to 6 weeks

时间窗: from baseline to follow up after 6 weeks

o Change in sleep disturbance from baseline to 6 weeks

时间窗: from baseline to follow up after 6 weeks

次要结局

  • • Secondary Outcomes:(o Incidence of adverse events: sedation, dizziness, edema, urinary retention, dry mouth etc.)

研究者

发起方
Dr Radhika Lakhtariya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Radhika lakhtariya

GEETANJALI MEDICAL COLLEGE AND HOSPITAL ,UDAIPUR

研究点 (1)

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