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【ChiCTR-IIR-17013331】Clinical Efficacy and Safety of Oral Supplement of Allium ascalonicum L. in Patients with Allergic Rhinitis

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基本信息

登记号

ChiCTR-IIR-17013331

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2017-11-10

临床申请受理号

靶点

适应症

Allergic Rhinitis

试验通俗题目

Clinical Efficacy and Safety of Oral Supplement of Allium ascalonicum L. in Patients with Allergic Rhinitis

试验专业题目

Clinical Efficacy and Safety of Oral Supplement of Allium ascalonicum L. in Patients with Allergic Rhinitis

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

(1) To determine the efficacy and safety of oral supplement of Allium ascalonicum L. in patients with mild-persistent allergic rhinitis (2) To compare the efficacy and safety of oral supplement of Allium ascalonicum L. to placebo in patients with mild-persistent allergic rhinitis (3) To observe the possible adverse effects of oral supplement of Allium ascalonicum L.

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

Randomization will be performed according to computer-generated schedule as described in www.Randomization.com

盲法

试验项目经费来源

Chiang Mai University

试验范围

目标入组人数

实际入组人数

第一例入组时间

2017-11-15

试验终止时间

2018-11-15

是否属于一致性

入选标准

Subjects will be male and female, aged 18-60 years old who were diagnosed with mild-persistent allergic rhinitis (according to ARIA 2008 guidelines) with previous history of positive skin prick test or presence of positive skin prick test to at-least 1 allergen during screening period. They must have total nasal symptom scores (TNSS) ≥ 6 within prior 2 weeks and the score of nasal congestion must not exceed 2 (≤ 2). All subjects must be explained and clearly understand the details of this research protocol, and give their written informed consent before entering the study.；

排除标准

Subjects were excluded from the study if they had: (1) marked anatomical abnormality of nose such as nasal septum deviation, nasal polyposis, unilateral obstruction; (2) infection of respiratory tract within 2 weeks before the study; (3) use of oral or intranasal corticosteroids within 4 weeks before the study; (4) nasal surgery within 4 weeks before the study; (5) currently on immunotherapy or previously received immunotherapy within 1 year before entering the study; (6) hypersensitivity of cetirizine or ingredient of the drug; (7) hypersensitivity of Allium ascalonicum L. or chemical in Allium ascalonicum L.; (8) history of asthma, cancer, hepatic diseases (AST, ALT > 1.5 times of the upper limit of normal range) or renal disease (eGFR < 50 ml/min), heart disease (using the digoxin); (9) pregnancy or breastfeeding.；

研究者信息

研究负责人姓名

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试验机构

Faculty of Medicine, Chiang Mai University

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研究负责人邮编

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