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)
- Conditions
- Health Condition 1: null- Common Cold (Coryza)
- Registration Number
- CTRI/2009/091/000879
- Lead Sponsor
- Merck Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response is defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell).Timepoint: Post 5 day treatment period
- Secondary Outcome Measures
Name Time Method -Fever evaluated by measuring the body surface temperature from auxillary pit <br/ ><br>-Dry cough evaluated on 4 point scale. <br/ ><br>Body ache evaluated on 0-10 Visual Analogue Scale (VAS) by clinical Investigator. <br/ ><br>-Change in the symptom scores <br/ ><br>-Physicians Global Assessment of Response to Therapy (PGART) on a 4-point scale. <br/ ><br>-Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale. <br/ ><br>Timepoint: -at baseline, day 3 & day 5.