A Prospective, Interventional, Multicenter, Post marketing Clinical Study of fixed dose combination of FLUCOLD SYRUP (Paracetamol 125 mg + Phenylephrine HCL 5 mg + Chlorpheniramine maleate 1 mg + sodium citrate 60 mg per 5 mL) syrup of Wallace Pharmaceutical Pvt. Ltd in the Treatment of common cold and flu syndrome in children

Wallace Pharmaceuticals Pvt Ltd0 个研究点目标入组 204 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Children with the age of 2 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.
•11.Use of any investigational drug currently or within 30 days prior to study entry.
•12.Subjects on any prescription medication that might interfere with study outcomes.
•13.Patients with severe hepatic, renal insufficiency.

发起方

Wallace Pharmaceuticals Pvt Ltd