An open-label, single-arm clinical study to evaluate the efficacy & safety of Malbet syrup in pediatric patients with uncomplicated influenza. - Nil

Solar Herbo Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

暂无简介。

•1)Male and female patients of age of 6-12 (Both inclusive) years visiting the outpatient department of the study center;2)Viral fever, cold, cough and pyrexia of unknown origin irrespective of the type of viral infection as per the discretion of investigator;3)At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity based on 5-point Linkert scale) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue;4)Has a fever less than or equal to 103 °F at the first visit or in the 6 hours prior if antipyretics were taken.

•1.Patients who required hospitalization at the time of screening;
•2.Fever > 103 °F;
•3.Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent;
•4.Suspected bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) as per discretion of investigator at the start of study;
•5.Patients having any congenital abnormality or epileptic attack
•6.Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs;
•7.Any other clinical condition which may jeopardize the study outcome or patient health in any way as per discretion of investigator.

发起方

Solar Herbo Pvt. Ltd.