A comparative study on safety and efficacy of oral fexofenadine and oral rupatadine among patients with allergic rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Safety and Efficacy of rupatadine and fexofenadine after seven days of treatment
研究概览
简要总结
STUDY OF COMPARISON****ON SAFETY AND EFFICACY OF FEXOFENADINE AND RUPATADINE AMONG PATIENTS WITH ALLERGIC RHINITIS.
Allergic Rhinitis is defined as having two or more symptoms of rhinorrhea, sneezing, nasal obstruction, anosmia/hyposmia and itching of nose during two or more consecutive days for more than 1 hour on most days. Allergic rhinitis is a common disease affecting0.8 to 39.7% of the world population.
A clinical history of rhinitis symptoms occurring in a temporal relationship to allergen exposure and documentation of sensitization to an environmental allergen are required for a diagnosis of allergic rhinitis. Although commonly seasonal due to elicitation by airborne pollens, it can be perennial in an environment of chronic exposure to house dust mites, animal danders, or insect (cockroach) products.Allergic Rhinitis is a common disease affecting 0.8 to 39.7 percent of the world depending on location.
OBJECTIVES
- To monitor the adverse drug reactions for safety profile of the drugs.
- To evaluate the Efficacy and cost effectiveness of the treatment groups.
MATERIAL AND METHODS
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Venue of Study: Department of Pharmacology with collaboration of Department of Oto-Rhino-Laryngology at Rama medical college and hospital and research centre, Kanpur.
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Type of study: The study will be comparative, observational, randomized, parallel group study.
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Duration of the study: Research study will be for 18 months.
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**Sample size:**142 patients of allergic rhinitis.
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Methodology**:** Patients with symptoms of allergic rhinitis visiting ENT OPD fulfilling inclusion criteria and exclusion criteria are taken in the study.
An appropriate number of patients (150) will be enrolled and will be divided into two groups via randomised method.
Group I will be administered drug Fexofenadine180mg OD for 7 days
Group II with drug Rupatadine 10mg OD for 7 days.
Patients who would lost to follow up or patient who would be not relieved after 7 days of drug therapy will be started with nasal corticosteroid and will be excluded from the study.
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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient of both the sexes in ages 16-60 years of age 2.having one or more features of allergic rhinitis such as sneezing, watery nasal discharge, itching in the nose/throat and nasal blockade.
- •3.Willing to give Informed & written consent.
- •4.SNOT score-22 with mild and moderate category.
排除标准
- •active disease like TB infection Pregnant and lactating women or willing to conceive with known history of hypersensitivity.
- •Patient above age 60 years lean and thin Any chronic diseases like CKD Hepatic diseases.
结局指标
主要结局
Safety and Efficacy of rupatadine and fexofenadine after seven days of treatment
时间窗: Baseline(Day 0),Day 7,Day14
次要结局
- Quality of life(Baseline(day 0),Day 7,Day 14)
研究者
Dr Kriti Jalota
Rama Medical college,kanpur