COMPARISON OF EFFICACY AND SAFETY OF ORAL BILASTINE WITH ORAL CETIRIZINE IN ALLERGIC RHINITIS-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- a. Total Nasal Symptom Score
研究概览
简要总结
Thesis Protocol titled COMPARISON OF EFFICACY AND SAFETY OF ORAL BILASTINE WITH ORAL CETIRIZINE IN ALLERGIC RHINITIS AN OPEN LABEL RANDOMISED CONTROLLED TRIAL will be done in North East India in department of pharmacology and otorhinolaryngology to compare the efficacy and safety of the most commonly used drugs for treamtents of Allergic Rhinitis that is oral bilastine and cetirizine Among2nd generation antihistaminic as an antiallergic only cetirizine has been included in NLEM 2022 But it has been reported that it has some adverse effect like headache sedation and dizziness so if a drug with better efficacy and safety profile can be identified through comparative studies it will be of great help for the patients suffering from Allergic Rhinitis hence this study has been taken up for comparison of the two molecules study period is of 78weeks, 70 weeks for data collection and sample size Case-Record Form containing History general physical examination systemic & local examination along with total nasal & non nasal symptoms score will be used the study tool Consent from particapnts will be taken Data will be entered & analysed in the SPSS version statistical software
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
- •All the newly diagnosed Seasonal Allergic Rhinitis patients attending ENT OPD of a Tertiary Care Hospital in the age group of 18 years & above shall be included the study.
排除标准
- •i Patient is suffering from perennial allergic rhinitis & and also from other from rhinitis like vasomotor rhinitis & URTI ii Patient having any other associated nasal condition like nasal polyp, tumour of nose, rhinosinusitis, any neoplastic condition of nose & PNS iii Those who have received any form of treatment for allergic rhinitis for last one month or receives steroids i All diagnosed patients of allergic fungal rhinosinusitis shall be excluded from the study v Pregnant women and lactating mother shall be excluded from the study vi Immunocompromised patients shall be excluded from the study.
结局指标
主要结局
a. Total Nasal Symptom Score
时间窗: at day 0 day 7 and day 14
b. Total Non-Nasal Symptom Score
时间窗: at day 0 day 7 and day 14
c. Mean Total Symptom Score
时间窗: at day 0 day 7 and day 14
次要结局
未报告次要终点
研究者
Anwesha Das
Agartala Government Medical College and GBP Hospital
