ISRCTN60440500已完成不适用
Efficacy, safety and tolerability of Influcid® tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms
Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany)0 个研究点目标入组 520 人开始时间: 2010年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 520
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
- 性别
- All
入选标准
- •1. Subjects aged 1 to 65 years
- •2. Diagnosis of upper respiratory tract infection
- •3. Written informed consent
- •4. Willingness and ability to comply with all trial procedures
排除标准
- •1. Severe or complicated course of the URTI
- •2. Signs of acute lower respiratory tract disease
- •3. Current symptoms mainly induced by other acute ENT (Ear-Nose-Throat) disease
- •4. Present chronic inflammatory ENT and respiratory tract disease
- •5. Obstructive anatomic lesions in the nasopharynx
- •6. Severe heart diseases, HIV-infection, unstable diabetes mellitus, coeliac disease and/or immunosuppression, tuberculosis and lues
- •7. Severe renal or hepatic dysfunction in past 12 months prior to enrolment
- •8. Children with congenital anomalies of heart, kidney or liver
- •9. Any significant alarm symptom within the past 6 months prior to enrolment
- •10. Evidence of any malignant disease during the past 5 years prior to enrolment
- •11. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •12. Hypersensitivity to any of the ingredients and/or excipients of Influcid®
- •13. Hypersensitivity to any of the ingredients and/or excipients as well as any known contraindications to the symptomatic treatment defined in this protocol
- •14. Positive rapid test for group A £]-hemolytic streptococci (GABHS)
- •15. Treatment with antibiotics, glucocorticosteroids, immunomodulators, or antihistamines during the past 4 weeks prior to or at enrolment as well as current indication requiring these drugs during the trial
- •16. Indication for administration of or treatment with antiviral drugs
- •17. Treatment with any antipyretics, nasal decongestants, expectorants and/or any other cold medication or measure for relief of URTI e.g. local anesthetics, anti-inflammatory drugs, antitussiva, homeopathic drugs, nutritional supplements or drugs containing zinc, echinacea, garlic or vitamin C (?d 100 mg per day), during the past 7 days prior to or at enrolment
- •18. Heavy smoking or known or suspected drug addiction
- •19. Inadequate contraception, pregnancy, lactation;
- •20. Participation in another clinical trial during the past 3 months prior to enrolment
- •21. Incompetence or incapability of understanding nature, meaning and consequences of the trial
研究者
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