A Multi-centric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Wikoryl DS oral suspension in children suffering from common cold associated with fever

It will be a Multicentric, Non-Randomized, Open label, Non-Comparative, Active PMS to evaluate the Safety and efficacy of Wikoryl DS Oral Suspension, FDC of Paracetamol 250 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg and Sodium citrate 60 mg per 5 ml in children suffering from Common cold with fever. The active PMS will be conducted for the duration of 5 days by the investigator. At

day 1 (baseline) the patient’s guardian will be informed about the study procedure and if agreed then his/ her sign on the informed consent form will be taken and patient will be recruited for the active PMS of Wikoryl DS Oral suspension . Based on the prescription of the principle investigator the guardians of the patient will give the patient the required medication for the period of 5 days starting from day 1 (visit 1). Also patient’s guardians will be asked to visit to the clinical trial site along with the patient at day 6 for safety and efficacy assessment. Symptom assessment at baseline and visit 2, will be done by principle investigator by measuring the symptom scores for fever, rhinorrhea, nasal congestion and sneezing on a four-point Likert scale for intensity (severity): 0= no symptom, 1 = mild, 2= moderate and 3= severe. Fever is characterized as 0= No fever (< 100.4), 1=Mild/low-grade fever (100.5–102.2 F) ,2=Moderate grade fever (102.2–104.0 F), 3= High grade fever High-grade (104.1–106.0 F).