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临床试验/CTRI/2025/02/081025
CTRI/2025/02/081025尚未招募4 期

Effect of Amitriptyline and Propranolol Prophylaxis on Heart Rate Variability and Lipid Profile in Persons with Migraine: A Prospective Cohort Study

Dr. Robin Reji1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月28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
120
试验地点
1
主要终点
1. changes in HRV on Amitriptyline and Propranolol prophylaxis

研究概览

简要总结

Migraine is a prevalent primary headache disorder marked by intense headaches and heightened sensitivity to sensory stimuli. Propranolol and amitriptyline are commonly prescribed for migraine prevention, but both medications can influence heart rate variability (HRV), impacting treatment outcomes. Research indicates that amitriptyline may reduce HRV, particularly in depressed patients, although it might enhance HRV in those experiencing neuropathic pain. In contrast, propranolol generally increases HRV, although its effects can vary among populations, such as those with hyperthyroidism. Additionally, amitriptyline is associated with unfavourable lipid profile changes, including elevated cholesterol and triglycerides. Given the established link between HRV and cardiovascular health, monitoring lipid profiles in patients treated with Propranolol and Amitriptyline is crucial to mitigate cardiovascular risks. This study aims to investigate the differential impacts of propranolol and amitriptyline on HRV and lipid profiles in migraine patients, ultimately enhancing migraine management strategies while addressing associated cardiovascular concerns.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed case of Migraine, according to the International Classification of Headache Disorders (ICHD-3) criteria Those who have given written informed consent for the study.

排除标准

  • History of significant cardiovascular disease (e.g., myocardial infarction, arrhythmias, heart failure) Patients with diabetes, HTN, dyslipidemia, Kidney and liver disease who are currently on medication Patients currently taking statins or other lipid-lowering therapies Patients with a history of severe psychiatric disorders Pregnant or breastfeeding women.

结局指标

主要结局

1. changes in HRV on Amitriptyline and Propranolol prophylaxis

时间窗: changes to be observed after 3 months of follow up after recruitment

次要结局

  • 1. change in lipid profile on Amitriptyline and Propranolol prophylaxis(2. Clinical response to migraine severity on propranolol and amitriptyline prophylaxis)

研究者

发起方
Dr. Robin Reji
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

ROBIN REJI

medical college block 1

研究点 (1)

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