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临床试验/NCT02000648
NCT02000648已完成不适用

Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
The recalcitrant symptoms of chronic rhinitis or chronic urticaria

研究概览

简要总结

Observation study of patients with chronic rhinitis or chronic urticaria in Thailand

详细描述

All patients presenting with symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per years or symptoms of chronic urticaria for at least 6 weeks will be asked to complete the case report forms asking for details of symptom characteristics, risk factors, personal habits, underlying diseases, and quality of life at the first visit. Investigation results, final diagnosis, and therapeutic interventions will also be recorded by the responsible allergist. On every follow-up appointment, patient symptoms, aggravating factors, medication use and side effects will be completed by patients. New findings, associated diseases, and prescriptions will be completed by allergist. The unfilled variables by patients will be asked in the following visit. Any "non-reported" variables those are unable to retrieve will be treated as missing data for data analysis. The estimated sample size is about 200 new cases per year.

Patient demographic data, clinical presentations, and associated diseases will be reported. The association between clinical characteristics and quality of life will be analyzed. The relationship between clinical manifestations and therapeutic outcomes will be determined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per year or symptoms of chronic urticaria for at least 6 weeks

排除标准

  • Less than 15 years of age

结局指标

主要结局

The recalcitrant symptoms of chronic rhinitis or chronic urticaria

时间窗: Baseline and 2 months after treatment

The alteration of symptoms at 2 months compared to baseline. Patient's complaining symptoms will be graded as likert scale system (0, 1, 2, 3). Any symptoms at 2 months after treatment that decrease less than 25% from base line based on average likert scale will be defined as "recalcitrant".

次要结局

  • The correlation between symptom severity and quality of life(At baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jettanong Klaewsongkram

Ass. Prof. Jettanong Klaewsongkram, MD.

Chulalongkorn University

研究点 (1)

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