EUCTR2005-005876-33-CZ进行中（未招募）不适用
A Randomised, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of nasal spray ANTIRIN® and NASIC® in the Treatment of Acute Viral Rhinitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Zentiva a.s.
- 入组人数
- 621
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •established diagnosis of acute viral rhinitis. All following criteria must be met:
- •odevelopment of nasal symptoms within 24 hours
- •opresence of nasal symptoms- congestion, rhinorrhea, nasal mucosa irritation ( itching or sneezing).
- •ooverall viral symptoms (at least one of them should be present) – weakness, headache, myalgia, arthralgia. (Febrile patients are not excluded from the trial.)
- •patients between 18 – 60 years, both sexes.
- •written informed consent obtained .
- •TNSS score on inclusion ( day 0) = 5.
- •the patient can be contacted by phone
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with history of allergic rhinitis, rhinitis sicca or rhinitis medicamentosa
- •pregnant or lactating women
- •patients with the history of bronchial asthma
- •patients with history of nose surgery, after the injury of the facial skelet, after actinotherapy of the facial region
- •patients with the history of endocrine disease
- •patients with the history of narrow angle glaucoma
- •patients taking the following drugs:
- •osystemic corticosteroid drugs within 1 month prior inclusion
- •olocally administered corticosteroid drugs within 7 days prior inclusion
- •oantihypertensive drugs that may influence nasal congestion within 7 days prior inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin,)
- •ouse of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 3 days prior inclusion
- •oMAO inhibitors and other drugs with hypertensive potential within 7 days prior inclusion
- •patients with the history of nasal polyps
- •any other disease or condition which may interfere with study assessments as judged by the investigator
- •alcohol or drug abuse
- •patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months
- •patients with history of hypersensitivity to the study drug or its excipients
- •clinically significant renal/hepatic impairment or serious heartdisease and uncontrolled hypertension
- •patients with pheochromocytoma
- •patients presenting any malignant disease
- •patients likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator
研究者
相似试验
进行中（未招募）
不适用
A Randomised, Double Blind, Placebo Controlled, Multi-centre, Parallel Group, Interventional Study of Mesalazine (Asacol®) Treatment in Irritable Bowel Syndrome and the Evaluation of Rectal Inflammation using the Diagnostic Tool 'Mucosal Patch Technique'MedDRA version: 16.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersIrritable Bowel SyndromeEUCTR2011-003418-18-NOSahlgrenska University Hospital200
进行中（未招募）
不适用
A Randomised, Double Blind, Placebo Controlled, Multi-centre, Parallel Group, Interventional Study of Mesalazine (Asacol®) Treatment in Irritable Bowel Syndrome and the Evaluation of Rectal Inflammation using the Diagnostic Tool 'Mucosal Patch Technique'Irritable Bowel SyndromeMedDRA version: 14.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-003418-18-SESahlgrenska University Hospital200
已完成
不适用
Clinical study to evaluate effectiveness, safety and efficacy of obinil Tablet in treatment of ObesityCTRI/2019/01/016879SAVA Healthcare Ltd
已完成
不适用
A Randomized, Double Blind, Placebo Controlled, Multicentre Clinical Trial to Assess the Efficacy and Safety of Amla Extract (AMX160) in Patients with DyslipidaemiaCTRI/2015/04/005682Arjuna Natural Extracts Ltd98
尚未招募
1 期
Clinical Study to Evaluate the Safety and Tolerability of in Healthy Human Volunteers for a period of 3 months for the safety endpoints.CTRI/2024/05/066786Himalaya Wellness Company