A Multicentric, non-randomized, open label, non-comparative, active post marketingsurveillance (PMS) to evaluate the safety and efficacy of Wikoryl Oral Drops in infants sufferingfrom Common cold with fever

It will be a Multicentric, Non-Randomized, Open label, Non-Comparative, Active PMS to evaluate the Safety and efficacy of Wikoryl Oral Drops, FDC of Paracetamol 125 mg, PhenylephrineHydrochloride 2.5 mg, Chlorpheniramine Maleate 1 mg, per 1 ml in children suffering from Commoncold with fever. The active PMS will be conducted for the duration of 5 days by theinvestigator. At day 1 (baseline) the patient’s guardian will be informed about the study procedureand if agreed then his/ her sign on the informed consent form will be taken and patient will berecruited for the active PMS of Wikoryl Oral Drops. Based on the prescription of the principleinvestigator the guardians of the patient will give the patient the required medication for the periodof 5 days starting from day 1 (visit 1). Also patient’s guardians will be asked to visit to the clinicaltrial site alongwith the patient at day 6 for safety and efficacy assessment. Symptom assessment at baseline andvisit 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 gradefever High-grade (104.1–106.0 F).