A Prospective, Interventional, Multicenter, Post marketing Clinical Study of fixed dose combination of FLUCOLD DROPS (Paracetamol 125 mg + Phenylephrine HCL 2.5 mg + Chlorpheniramine maleate 1 mg per ml) drops of Wallace Pharmaceutical Pvt. Ltd., in the Treatment of common cold and flu syndrome in infants and children

Wallace Pharmaceuticals Pvt Ltd0 sites220 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 23, 2021

Last Updated

3 years ago

Study Type

Interventional

Sponsor

Wallace Pharmaceuticals Pvt Ltd

•1\.Infants and Children with the age from 6 months to 12 years
•2\.Presented symptoms of recent onset for more than 6 hours and less than 72 hours characterizing one of the following conditions
•the common cold, which consists of at least 2 symptoms among the 10 following sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points
•The flu syndrome, which consists of high grade up to 104 .F and headache of moderate or severe intensity or chest discomfort, decrease appetite, dizziness using a scale of severity of symptoms of 4 points
•3\. Willing to provide written assent form by parents for participation in the study and adhere to the protocol requirements

•1\.Patients representative who are not willing to give written assent form.
•2\.Any known hypersensitivity to the study products.
•3\.Any history of seasonal or perennial allergic rhinitis.
•4\.Patients who have taken treatment for the presenting symptom within 7 days of screening.
•5\.Patients who received influenza vaccine within 7 days of screening.
•6\.Patients who in the opinion of attending physician may need receive antibacterial drugs for the treatment of acute respiratory infection.
•7\.Any lab findings or clinical findings that in the opinion of treating physician may appear as risk to the patient.
•8\.Participation in any clinical trials prior to 12 months.
•9\.Any finding of clinical observation that is interpreted by the physician investigator as a risk to the patients participation in the study.
•10\.Severely immune compromised patients.