ChiCTR-IIR-17013331
正在进行
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2017-11-10
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Allergic Rhinitis
Clinical Efficacy and Safety of Oral Supplement of Allium ascalonicum L. in Patients with Allergic Rhinitis
Clinical Efficacy and Safety of Oral Supplement of Allium ascalonicum L. in Patients with Allergic Rhinitis
(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.
随机平行对照
Ⅱ期
Randomization will be performed according to computer-generated schedule as described in www.Randomization.com
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Chiang Mai University
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60
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2017-11-15
2018-11-15
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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.；
请登录查看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.；
请登录查看Faculty of Medicine, Chiang Mai University
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