CTRI/2010/091/001368已完成3 期
A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The change in the total symptom score
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of Acrivastine 8 mg capsules and Chlorpheniramine maleate 4 mg tablets given thrice daily each for 2 weeks; in 200 patients with allergic rhinitis that will be conducted in India. The primary outcome measures will be the change in total symptom score of nasal and ocular symptoms during the course of study.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex of 18 to 65 years of age 2.Established diagnosis of allergic rhinitis 3.Informed consent.
排除标准
- •1.Pregnancy & Lactation.2.Significant renal impairment.3.Narrow-angle glaucoma, GI or GUT obstruction.4.Patients with acute attack of bronchial asthma or those on corticosteroids.5.Nasal structural abnormalities6.Upper respiratory tract infection7.Hypersensitivity to study medications8.Patients with any other serious concurrent illness or malignancy9.Continuing history of alcohol and / or drug abuse10.Recent participation in another clinical trial.
结局指标
主要结局
The change in the total symptom score
时间窗: 0,1,2 weeks
次要结局
- The change in the total and individual nasal and ocular symptom scores(0,1,2 weeks)
研究者
研究点 (5)
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