KCT0003760已完成未知
Efficacy and safety of NVP1703 on allergic rhinitis; A 4week, Multi-center, Double-blind, Randomized, Placebo-Controlled Clinical Trial
avipharm0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •(1)A person who has agreed to participate in a clinical trial and signed on the informed consent form.
- •(2) Adult men and women aged 19 and over, 65 and under
- •(3)Persons with allergic rhinitis who are at least 2 years of continuous (perennial)
- •(4) those who have above two points in more than two nasal symptoms * (snoring, sneezing, watery rhinorrhea, nasal congestion) in the run-in period between visit 1 and visit 2.(*Can participate when satisfied with morning or evening scores)
- •(5) Allergic skin prick test results showed positive reaction
- •(6) Those who do not take medicines and health functional foods to reduce nose symptoms during the run-in period
排除标准
- •(1) A person who can not stop medication that can affect allergic rhinitis due to diseases other than allergic rhinitis during the study period
- •(2)Screening criteria Within 2 weeks, a corticosteroid for the whole body, cromolyn for nasal administration, or an antihistamine administered within 3 days of screening
- •(3)Probiotics health functional foods within one week of screening criteria and those who take fermented milk continuously (more than 4 times a week)
- •(4)Currently undergoing gastritis and gastric ulcer treatment
- •(5)Current asthma treatment
- •(6)Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the last 6 months(However, patients who have a history of cerebrovascular disease or heart disease but are clinically stable can participate in the test by the judgment of the investigator)
- •(7)People with mental disorders such as depression, schizophrenia, alcoholism, drug addiction
- •(8)Patients with uncontrolled hypertension (> 170/100 mmHg, based on screening)
- •(9)Patients with uncontrolled diabetic(fasting blood sugar 180 mg / dl or higher, based on screening)
- •(10) Creatinine is at least twice the normal upper limit of the testing laboratory
- •(11) AST (GOT) (Asparate Aminotransferase) or ALT (GPT) (Alanine Aminotransferase) is at least twice the normal upper limit of the test laboratory.
- •(12) Any person who is pregnant or who has a pregnancy plan for the duration of the trial
- •(13) Any person deemed inadequate by the investigator for other reasons
- •(14) Persons sensitive or allergic to the investigational product
- •(15) If you have participated in another clinical trial within one month of the start of this human body test or plan to participate in another clinical trial during the trial period
研究者
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