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临床试验/CTRI/2025/09/095235
CTRI/2025/09/095235尚未招募不适用

COMPARISON OF EFFICACY AND SAFETY OF ORAL BILASTINE WITH ORAL CETIRIZINE IN ALLERGIC RHINITIS-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL

Anwesha Das1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月13日最近更新:

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

发起方
Anwesha Das
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anwesha Das

Agartala Government Medical College and GBP Hospital

研究点 (1)

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