DRKS00018081已完成4 期
Homeopathy for Seasonal Allergic Rhinitis (HOMEOSAR) – A Randomised Controlled Trial - HOMEOSAR
Charité - Universitätsmedizin BerlinInstitut für Sozialmedizin, Epidemiologie und Gesundheitsokönomie0 个研究点目标入组 62 人开始时间: 2020年6月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Patients aged = 18 and = 75 years
- •On average, moderate to severe seasonal allergic rhinitis (SAR) symptoms over a period of at least 2 pollen seasons
- •Visual analogue scale (VAS) score = 40mm and = 80mm for SAR symptoms as assessed by the patients for the week before the inclusion
- •Positive skin prick test and/or radioallergosorbent (RAST) test positive for both, birch and grass pollen
- •Use of, or indication for, oral antihistamines as anti-allergic medication
- •Written informed consent (obtained before the first assessment is performed)
- •Availability for the entire duration of the study
- •Ability to adhere to the study procedures and visit schedule
排除标准
- •Perennial allergic rhinitis or other types of chronic rhinitis
- •History of anaphylactic reactions
- •In accordance to GINA criteria asthma with the following criteria: a.) occurrence of asthma symptoms more than twice per week, b) any night waking due to asthma, c) reliever (beta-2-sympathomimetic drug) needed more than twice per week, excluded reliever taken before exercise, d) activity limitation due to asthma. The patient is excluded if more than one criterion is met.
- •Moderate to severe atopic dermatitis
- •Current daily use of topical or systemic corticosteroids
- •Known hypersensitivity to Galphimia glauca or other homeopathic drugs
- •Allergen-specific immunotherapy currently or within the past 3 years
- •Homeopathic therapy currently or within the past 6 weeks
- •Use of other complementary and integrative medicine treatments for SAR currently or within the past 6 weeks
- •Alcohol addiction
- •Pregnancy or breastfeeding
- •Serious acute or chronic organic disease or serious mental disorder
- •Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian), or other vulnerable patients (e.g. under arrest)
- •Simultaneous participation in any other clinical trial
- •Employees or family members of the sponsor or investigators
- •Acute infection with SARS-COV-2 virus
- •Long-COVID-syndrome
- •Positive SARS-COV-2 PCR or antigen rapid test within the last 24 hours
研究者
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