A Prospective, Multicenter, Open-Label, Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of An Appetite Stimulating Tonic In Children.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 6
- 主要终点
- 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.
研究概览
简要总结
This prospective, multicenter, single-arm, open-label, post-marketing observational study is designed to evaluate the effectiveness and safety of appetite-stimulating tonic Betonin AST in the management of Indian children and adolescents with loss of appetite (LOA) due to acute or chronic illness. In this study, 380 pediatric patients with LOA (due to any acute or chronic illness) and prescribed the Betonin AST syrup, at a dose of 5 ml twice daily (BID), will be enrolled in the study for a period of 14 (±1 day) days.
The selection of patients for the study will be totally at the discretion of the investigator. All patients diagnosed with LOA, meeting inclusion & exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this study.
At the baseline (Visit 1 [Day 0]), informed consent from the parents of all the children plus oral assent from pediatric patients in the age group of ≥7 to ≤11 years in the presence of the parent or legally acceptable representative (LAR); written assent from pediatric patients in the age group of >11 to ≤15 years will be taken (For children in the age group of ≥6 to <7 years, parental consent is sufficient),59 before assessing the pediatric patient’s eligibility and entry into the study. Pediatric patients having LOA (due to any acute or chronic illness) fulfilling all of the inclusion and violating none of the exclusion criteria will be enrolled in the study.
Post entry of a pediatric patient into the study demographic details- age, gender, and socioeconomic status, will also be captured and clinical examination, which will include a record of vitals (including blood pressure (BP), pulse rate (PR), respiratory rate (RR) and body temperature), anthropometric measurements (Height, Weight, BMI), and physical and systemic examination, will be done. Detailed medical history (including duration of disease, co-existing condition, etc.) will be taken.
At baseline (Visit 1 [Day 0]), pediatric patients with LOA (due to any acute or chronic illness) will be evaluated for meal frequency and quantity of food consumed per day. The patient will continue receiving the Betonin AST syrup, at a dose of 5 ml twice daily (BID), for 14 days at the baseline. The progress made by the pediatric patients will be reviewed in the clinic on Days Seven (7) (±1 day) and 14 (±1 day). Pediatric patients will be evaluated for change in interest in food and the amount of food consumed compared with usual intake, and the safety and tolerability of the Betonin AST syrup assessed by monitoring the incidence of treatment-emergent adverse events (TEAE).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female pediatric patients in the age group of ≥6 to ≤15 years.
- •Pediatric patients diagnosed by a pediatrician as having LOA (due to any acute or chronic illness)
- •Pediatric patients prescribed the Betonin AST syrup, along with the standard of care for the acute or chronic illness of the pediatric patient.
- •Accompanying parents or LAR who can understand study requirements and are willing to provide written informed consent for the childs participation.
- •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).
- •Parents and pediatric patients willing to comply with study procedures and requirements.
排除标准
- •Patient taking any ayurvedic/any medications for appetite loss for the past 2 months before the screening date.
- •Patients with a known history of hypersensitivity to any component of the study drug.
- •Patients with a known condition which according to investigators may interfere with the absorption or metabolism of study drugs.
- •Patients with a known history of behavioral or psychiatric issues, and/or congenital heart disease.
- •Patients with any other conditions or diseases/medication that the investigator considers ineligible to enroll in the study based on approved prescribing information.
- •Patients with suspected inability or unwillingness to comply with study procedures.
结局指标
主要结局
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.
时间窗: Day 0, 7 & 14
次要结局
- 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).)