Clinical Efficacy and Safety of Oral Supplement of Allium ascalonicum L. in Patients with Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total nasal and ocular symptom scores (TNSS and TOSS)
研究概览
简要总结
(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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 18 至 60（—）
- 性别
- All
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.
研究组 & 干预措施
1
Cetirizine 10 mg 1 tablet hs+supplement of Allium ascalonicum L. (500 mg) 3 capsules bid
2
Cetirizine 10 mg 1 tablet hs+placebo 3 capsules bid
结局指标
主要结局
Total nasal and ocular symptom scores (TNSS and TOSS)
时间窗: Every morning by assessing the allergic symptoms during the past 24 hours for 28 days
Visual analog scale of overall symptoms scores (VAS)
时间窗: Day 0, 14, 28 of study
Quality of Life
时间窗: Day 0, 28 of the study
Subject satisfaction
时间窗: Day 28 of study
Nasal cytology
时间窗: Day 0, 14, 28 of the study
Nasal airway resistance (NAR)
时间窗: Day 0, 28 of the study
Any adverse event
时间窗: Throughout the study
Laboratory investigation for complete blood count (CBC), creatinine level (Cr), AST, and ALT
时间窗: Day 0, 28 of the study
次要结局
未报告次要终点