NL-OMON27660招募中不适用
Efficacy and tolerability of Citrus/Cydonia comp.solution for injection in patients with grass pollenseasonal allergic rhinitis:Randomised, double-blind, placebo-controlled comparative clinical trial with three parallel treatment groups The CiSAR Study
ectoraat Antroposofische GezondheidszorgHogeschool LeidenCluster ZorgZernikedreef 11 (D0.036)Postbus 382, 2300 AJ LEIDENT: +31 71 51 88 769M: +31 6 468 468 040 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
入选标准
- •1.Written informed consent
- •2.Age ≥ 18 and < 60 years
- •3.Seasonal allergic rhinitis:
- •-Duration of respective complaints at least 2 years
- •-Suffering from the following nasal symptoms: sneezing, itching nose, nasal obstruction and
- •watery nasal discharge
- •-Severity score of at least two of the four nasal symptoms ≥ 2 (ranging from 0 = not present to 3= severe)
- •-Suffering from the following non-nasal symptoms: itchy/burning eyes, watery eyes, redness of eyes and itching ears/throat
- •-Severity score of at least two of the four non-nasal symptoms ≥ 2 (ranging from 0 = not present to 3 = severe)
- •-The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for at least two previous years
- •-Average Total Symptom Score in the wash-out period ≥ 9 on days with a pollen count > 20 or use of rescue medication on days with a pollen count > 20.
排除标准
- •1.Chronic inflammatory autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
- •2.Known hypersensitivity to one of the constituents of Citrus/Cydonia comp.
- •3.Participation in a further clinical trial at the same time or within the previous 4 weeks prior to enrolment into this study
- •4.Previous use of medicinal products containing Citrus and/or Cydonia
- •5.Pregnancy or lactation
- •6.Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
- •7.A known history of drug, alcohol and/or medication dependence or addiction
- •8.Immunotherapy in the last two years
- •9.Use of cromoglycates
- •10.Other allergies (non seasonal allergies)
研究者
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