CTRI/2025/04/084435尚未招募4 期
Effectiveness of bilastine versus Levocetirizine in children with allergic rhinitis.
self funded1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年4月16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
- 160
- 试验地点
- 1
- 主要终点
- Measuring the change in allergic symptoms as assessed by the total reflective total nasal symptom score
研究概览
简要总结
This study is randomised controled trial comparing effectiveness of bilastine versus levocetirizine in children with allergic rhinitis.This study is being done in aiims pediatric department, using the score rtnss children of age 6-18years are being included into the study randomly and they are supplemented with bilastine or levocetirizine and will be asessed after 2weeks with rtnss scores comparing with the baseline scores.overall duration of study is estimated to be 18months.
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
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 6-18 years of age group with AR And Having a minimum reflective total nasal symptom score of 3 on at least 4 days in the previous 7 days.
排除标准
- •Children with known hypersensitivity to any of the study drugs Children who have received any of the following drugs in the preceding 7 days that is oral or intranasal corticosteroids oral or intranasal antihistamines or leukotriene receptor antagonists like montelukast Children with history of upper respiratory tract infection in the previous 7 days Children with any of the following disorders structural diseases of the nose or chronic sinusitis or chronic liver disease or chronic kidney disease or intellectual disability or congenital or acquired heart disease or diabetes or malignancies or primary or secondary immunodeficiency or coagulation disorders.
结局指标
主要结局
Measuring the change in allergic symptoms as assessed by the total reflective total nasal symptom score
时间窗: 2weeks
次要结局
- The individual rTNSS scores(The overall scores on the MiniRQLQ)
研究者
Jyoshna Nidamanuri
AIIMS Mangalagiri
研究点 (1)
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