None listed
Conditions
Interventions
Intervention1: Baalprashan Swarnaprashan Drops: 2 drops of Baalprashan Swarnaprashan Drops daily for 5-10 years of participants and 3 drops of Baalprashan Swarnaprashan Drops daily for 11-15 years of
Sponsors
Natureovedic Consumers Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all of the following criteria will be eligible for the study: 1. Male and female participants aged between 5 to 15 years (both inclusive) 2. Children having recurrent episodes of upper respiratory tract infections (defined as greater than 4 episodes of upper respiratory tract infections during the period 3 months prior to enrollment in the study) 3. Participants parents understand and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Participant has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product 2. Participant has a current illness requiring hospitalization 3. Participant has a gastrointestinal infection and or acute diarrhea at the time of inclusion in the study 4. Participant is currently taking medication that could affect absorption or metabolism of study product or weight of the child. Exception: Topical or ocular steroids will be permitted during the study 5. Participant is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma. (As per history and documentation in the medical records) 6. Participant has active or history of tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records) as per discretion of investigation 7. Participant has a history of diabetes mellitus (as per history and documentation in the medical records) 8. Participant has been on antibiotic therapy within the last one month before start of the study (before study Day 1) 9. Participant has dysphagia, aspiration risk, and difficulty in swallowing due to acquired or congenital abnormalities that would hamper oral intake of the study product. (As per history and documentation in the medical records) 10. Participant has a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator 11. Any condition that could, in the opinion of the investigator, preclude the participants or parents ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Height, weight, chest circumference and mid-upper arm circumference 2. Weight and height (WHO z-score) 3. Immunity profile - number of recurrent acute upper respiratory tract infection (URTI), number of sick days per month assessed, number of days required to recover from episode of infectionTimepoint: 1. Screening, day 30, day 60 and day 90 2. Screening and day 90 3. Screening, day 30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Growth, stamina and immunity by Clinical global impression–improvement scale score by parent and investigator 2. Immunoglobulins A and GTimepoint: 1. Day 90 2. Screening and end of study | — |
Countries
India
Contacts
Public ContactDr Urvi Ashani
Natureovedic Consumers Private Limited
Outcome results
None listed