CTRI/2009/091/000879已完成3 期
A Phase III Randomized Controlled Study Of Efficacy & Tolerability Of Fixed Dose Combination Of Paracetamol 500 Mg + Phenylephrine Hydrochloride 5mg + Diphenhydramine 25 Mg + Caffeine 30 Mg (Nasivion Tablets) Versus Paracetamol 500 Mg And A Fixed Dose Combination Containing Paracetamol 500 Mg + Chloropheneraminemaleate 2 Mg + Phenylephrine 10 Mg (Control) In Patients With Common Cold (Coryza)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
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.All subjects selected for this study will be within the age group of 18 to 60 years.
- •2.Patients suffering from common cold (coryza) associated with symptoms of rhinorrhoea, nasal congestion and fever.
- •3.Patients who have provided with their informed consent.
- •4.Patients who can come for follow-up as per the study schedule
排除标准
- •1.Patients with known hypersensitivity to ingredients of study/active comparators.
- •2.Patients with productive cough.
- •3.Patients with clinical suspicion of any local (nasal) or systemic bacterial infection.
- •4.Patients having hypertension (defined as sitting blood pressure of >140 mm systolic and/or 90 mm diastolic)
- •5.Patients with any previous H/O or current episode of cardio-vascular disorders.
- •6.Known renal or hepatic illness.
- •7.Pediatric and Pregnant patients.
- •8.Patients with H/O drug/alcoholic/substance abuse.
- •9.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study
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