A Prospective, Open label, Single arm, Single Centre Study for Assessment of Efficacy, Safety and Cost analysis of add-on Pidotimod 400mg in maintenance therapy for recurrent Acute Respiratory Tract Infections in Paediatric Patients

Dr K Nagaraju0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Pediatric Patients ( >= 2 years and <= 12years, both inclusive) of either gender who are suffering from recurrent ARTIs (defined as >= 3 episodes / year or >= 15 days of respiratory illness in past 3 months)
•2.Patients / Legal guardians who understand the nature of the study and are willing to provide written informed consent.

•1.Patients with known allergic / hypersensitivity reaction to study medication.
•2.Patients who have been vaccinated in last 3 months for Respiratory illnesses (viz. Hemophilus Infuenza B, Pneumococcal vaccine, Influenza vaccine)
•3.Patients with diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly like Cerebral Palsy.
•4.Patients who had received any course of antibiotics or a course of systemic steroids within one month prior to enrolment into the study
•5.Patients with history of receiving any other immuno-modulator drug in the past 6 months.
•6.Patients who are diagnosed with serious respiratory disorders or, illnesses like pneumonia, Cystic fibrosis, Bronchiectasis.
•7.Patients with history of other systemic disorders like cardiovascular, Hepatic, Renal or neoplastic disorders deemed to be inappropriate for study participation.
•8.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
•9.Subject who had participated in any clinical trials in past 2 months
•10.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

发起方

Dr K Nagaraju