A Prospective, Multicenter, Open-Label, Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of An Appetite Stimulating Tonic In Children. - NI

Abbott Healthcare Private Limited0 个研究点目标入组 380 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•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 <7 years, parental consent is sufficient).
•6. Parents and pediatric patients willing to comply with study procedures and requirements.

•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.

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