CTRI/2021/11/038228已完成不适用
“COMPARISON OF EFFICACY AND TOLERABILITY OF LEVOCETIRIZINE WITH MONTELUKAST-LEVOCETIRIZINE COMBINATION AS AN ADD-ON THERAPY IN MIGRAINE PROPHYLAXISâ€,-An open label, Prospective, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- End points of the study1.Proportion of patients with 50% reduction in frequency of attacks at the end of 3rd month of the study
研究概览
简要总结
Histamine has been known to play an important role in the pathogenesis of
vascular headache and the role of antihistamines in the role of Migraine
prophylaxis need to be studied (1).
Few studies suggest that there is an increased levels of Histamine in Migraine patients during the head ache attack and the symptom free period(2).
The relationship between allergy and migraine can be based, in part, on an IgE-mediated mechanism, and histamine release plays an important role. Thus avoidance of allergic conditions in migraine patients may be a simple, helpful way for prophylaxis of migraine.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Migraine headache as per ICHD-3 criteria Patients fulfilling the criteria for the prophylaxis of Migraine Age group of 18-60 years of age Sex- Both male and female Patients who are willing to participate in this study.
排除标准
- •Patients with headache other than migraine Patients with complicated migraine like ophthalmic, hemiplegic or migraine with brainstem aura Patients with H/O severe drug allergy Patients with H/O severe co-morbidities like hypertension, Coronary artery disease, uncontrolled Diabetes Mellitus, thyroid disease, renal or liver disease, asthma.
- •H/O any drug abuse or drug dependence Patients with H/O any psychiatric illness Pregnant ladies, lactating mothers and children less than 18 years of age.
结局指标
主要结局
End points of the study1.Proportion of patients with 50% reduction in frequency of attacks at the end of 3rd month of the study
时间窗: At 3rd month of study
次要结局
- To assess the reduction in frequency and severity of pain intensity at the end of 6th month of the study(To observe for any adverse effect with study drug)
研究者
研究点 (1)
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