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
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Clinical response is defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell).
研究概览
简要总结
This study is a randomized , open label phase 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) with 4 centres all across India. The study period is for 5 days and roughly 200 patients will be included in the study, 50 patients at each site. The primary outcome will be the clinical response defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell. The estimated number of patients is 200 for 4 sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Clinical response is defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell).
时间窗: Post 5 day treatment period
次要结局
- -Fever evaluated by measuring the body surface temperature from auxillary pit(-Dry cough evaluated on 4 point scale.)