Health Condition 1: null- Acute Respiratory Tract Infections in Paediatric Patients
Conditions
Interventions
Intervention1: Pidotimod: 400mg twice daily for 15 days followed by 400mg once daily till completion of 2 months of therapy
Control Intervention1: Nil: Nil
Sponsors
Dr K Nagaraju
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pediatric Patients ( >= 2 years and = 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in the number of episodes of ARTIsTimepoint: End 6 months after commencement of Pidotimod treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Average duration of each episode of ARTITimepoint: End 6 months after commencement of Pidotimod treatment;2. Number of episode requiring antibiotic therapyTimepoint: End 6 months after commencement of Pidotimod treatment;3. Average duration of antibiotic therapy required per episodeTimepoint: End 6 months after commencement of Pidotimod treatment;4. Change in incidence of use of reliever medications like SABA, NebulizationTimepoint: End 6 months after commencement of Pidotimod treatment;5. Number of school days lost due to ARTITimepoint: End 6 months after commencement of Pidotimod treatment;6. Number of workdays lost (of care givers) due to ARTITimepoint: End 6 months after commencement of Pidotimod treatment;7. Change in cost of medical management (direct & indirect) and hospital expenses after therapy with PidotimodTimepoint: End 6 months after commencement of Pidotimod treatment | — |
Countries
India
Contacts
Public ContactDr K Nagaraju
Saveetha Medical College
Outcome results
None listed