A clinical study to evaluate efficacy and safety of Appetol syrup in children suffering from non-specific anorexia
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of Appetol syrup in children suffering from non-specific anorexia by assessing SNAQ Scale
研究概览
简要总结
This study is an Open Labeled, Non-comparative,Prospective, Single Center Clinical Study to evaluate efficacy and safety ofAppetol syrup in children suffering from non-specific anorexia. The study willbe done in 50 completed patients. Appetol Syrup will be given in a dose of 10ml twice daily after meals for 45 days. After 45 days all the patients will be advisedto stop taking medicine and will be monitored for next 15 days to observerecurrence of symptoms. The trial will be conducted at Department of Balrog, Govt.Ayurvedic College, Tuljapur Road, Osmanabad. Primary outcome will be toevaluate efficacy of Appetol syrup in children suffering from non-specificanorexia by assessing SNAQ Scale. Secondary outcomes will be to evaluateefficacy of Appetol syrup in children suffering from non-specific anorexia byassessing Weight and BMI, Activity level on PAQ-C Scale, Abdominal pain/cramps,abdominal distension, flatulence, constipation, nausea, vomiting, Overallimprovement by Physician and Patient’s LAR at the end of the study, acceptabilityof drug, Drowsiness or sedation, Adverse events and drug tolerability bypatient’s LAR and physician at the end of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1 The informed consent document must be read signed and dated by subjects legally authorized representative before conducting any study procedures or examination 2 Males and females between 5 to 9 years of age 3.Subjects suffering from non specific anorexia 4.Subjects having normal vital parameters.
排除标准
- •1 Children with SNAQ score less than or equal to 14 2 Children with chronic illnesses congenital abnormalities 3 Subject who is on other appetite stimulants sedatives narcotics and steroidal drugs 4 Subjects who have received treatment another investigational agent within last thirty days from Screening Visit 5 Subjects who have received chemotherapy or radiation therapy within the past 5 years 6 Subjects on systemic antibiotics or systemic therapy with cytotoxic drugs 7 Subjects having metabolic and or endocrine disorders 8 Subjects with any type of GI tract disorder including malabsorption syndrome etc 9 Subjects with liver and renal disorders 10 Subjects with known immunological, hematologic disorders or malignancy 11 Subjects having known neurological or psychiatric pathologies 12 Subjects with history of raised levels of cortisol abnormalities of thyroid hormone growth hormone and insulin secretion 13 Subject or LAR refuse to sign informed consent form 14 Subjects having a known hypersensitivity to Appetol Syrup and any of the ingredients of Appetol Syrup.
结局指标
主要结局
To evaluate efficacy of Appetol syrup in children suffering from non-specific anorexia by assessing SNAQ Scale
时间窗: 0 day 15 day 30 day 45 day and 60 day
次要结局
- 1 Weight and BMI(2 Activity level on PAQ-C Scale)