Health Condition 1: R630- Anorexia
Conditions
Interventions
Intervention1: Betonin AST Syrup: In this PMOS pediatric patients with loss of appetite (due to any acute or chronic illness) will continue receiving Betonin AST syrup (as per the routine clinical pra
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female pediatric patients in the age group of =6 to =15 years. 2. Pediatric patients diagnosed by a pediatrician as having LOA (due to any acute or chronic illness) 3. Pediatric patients prescribed the Betonin AST syrup, along with the standard of care for the acute or chronic illness of the pediatric patient. 4. Accompanying parents or LAR who can understand study requirements and are willing to provide written informed consent for the childs participation. 5. Pediatric patients in the age group of =7 to =11 years willing to provide oral assent, and patients in the age group of >11 to =15 years willing to provide written assent, in the presence of the parent or LAR (For children in the age group of =6 to 6. Parents and pediatric patients willing to comply with study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1. Patient taking any ayurvedic/any medications for appetite loss for the past 2 months before the screening date. 2. Patients with a known history of hypersensitivity to any component of the study drug. 3. Patients with a known condition which according to investigators may interfere with the absorption or metabolism of study drugs. 4. Patients with a known history of behavioral or psychiatric issues, and/or congenital heart disease. 5. Patients with any other conditions or diseases/medication that the investigator considers ineligible to enroll in the study based on approved prescribing information. 6. Patients with suspected inability or unwillingness to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of 14-day therapy with the appetite-stimulating medication in improving the appetite of children in the age group of 6 to 15 years.Timepoint: Day 0, 7 & 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the quantitative effects of the appetite-stimulating medication in improving the appetite of children in the age group of =6 to =15 years, at Days 7 (±1 day) & 14 (±1 day) of therapy. 2. To evaluate the treatment compliance at the end of the study on Day 14 (±1 day). 3. Global assessment of effectiveness, as rated by the physicians and patients.Timepoint: Day 0, 7 & 14 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott Healthcare Private Limited
Outcome results
None listed