Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
None listed
Sponsors
Kishor Gavali
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged 3-12 years of either sex. 2. Participants with a history of respiratory tract infections a. at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 episodes for those aged 3-5 years old at inclusion; 5 episodes for those aged 6-12 years old at inclusion b. OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months 3. Parent(s) /legal guardians willing to provide a written informed consent form for the participation of their children.
Exclusion criteria
Exclusion criteria: 1. Children with Weight for Age Z Score (WAZ) less than -3 as per WHO standards. 2. Children with diagnosed congenital heart disease, Rheumatic immune disease, congenital deformity of the trachea, chronic pulmonary disease, chronic liver and kidney disease, etc. that are judged by the investigator that could be detrimental to the participant or could compromise the study 3. Children with diagnosed case of tuberculosis. 4. Participant with any immunodeficiency condition, either primary or secondary like Acquired immunodeficiency syndrome AIDS, cancers of the immune system, immune-complex disease, chemotherapy, and radiation) 5. Participant with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit. 6. H/o hypersensitivity to any of the trial drugs or their ingredients. 7. The patient participated in another clinical trial in the last 2 months. 8. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Incidence rate of respiratory tract infection (RTI) episodes Total number of clinically defined RTI episodes per child during the overall study period (treatment + post-treatment follow-up) will be compared between the treatment groups.Timepoint: at baseline, 28th, 56th, 84th, 112th, 140th and 168th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Frequency, duration, and number of courses of antibiotics, antipyretics, anticold, and antitussive preparations Number of courses + total days of use for each category during the overall study period (treatment and post-treatment follow-up) will be compared between the treatment groups.Timepoint: baseline, 28th, 56th, 84th, 112th, 140th and 168th day;3. Hospitalization episodes and hospitalization days due to RTIs infections during the overall study period (treatment and post-treatment follow-up) will be compared between the treatment groups.Timepoint: baseline, 28th, 56th, 84th, 112th, 140th and 168th day;4. Effect on Immunoglobulin Levels will be assessed through serum IgG, IgA, and IgE levels.Timepoint: baseline and 56th day;5. Change in mean Weight for Age Z score, Height for Age Z score and BMI for Age Z score by assessing Height and weight.Timepoint: baseline,56th, 112th and 168th day;Safety will be assessed through biochemical parameters CBC, LFT, and KFTTimepoint: Baseline and 168th Day;1. Total number of symptomatic days with Respiratory Tract Infection (RTI). Comparison of total days with Respiratory Infections (RI) during the defined period. The total number of days with RI during the overall study period (treatment and post-treatment follow-up) will be compared between the treatment groups.Timepoint: baseline, 28th, 56th, 84th, 112th, 140th and 168th day | — |
Countries
India
Contacts
Public ContactKISHOR GAVALI
M. S. Regional Ayurveda Research Institute, Jaipur
Outcome results
None listed