The efficacy and safety of So-Cheong-Ryong-Tang for perennial allergic rhinitis : a double-blind, randomized, parallel-group, multi-center trial

Kyung Hee University0 个研究点目标入组 154 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•(1) age 19-60 years;
•(2) presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score = 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom);
•(3) presence of nasal symptoms more than 2 consecutive years; and
•(4) positive reaction to the one or more perennial allergen in skin prick test.

•(1) treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week;
•(2) presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses);
•(3) presence of hypertension (systolic = 180 mmHg or diastolic = 100 mmHg);
•(4) presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) = 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) = 30 mg/dL or creatinine = 1.8 mg/dL (male), 1.5 mg/dL (female));
•(5) presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis;
•(6) history of drug allergy;
•(7) history of anaphylaxis for allergic tests;
•(8) pregnancy or lactation; or
•(9) participation of other clinical study within the past 3 months.

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