Effects of Pidotimod 400mg for repeated attacks of Respiratory Tract Infections in childre

Phase 4

• Conditions: Health Condition 1: null- Acute Respiratory Tract Infections in Paediatric Patients

• Registration Number: CTRI/2018/02/011898
• Lead Sponsor: Dr K Nagaraju

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified