CTRI/2014/07/004756已完成2 期
A clinical study to evaluate efficacy and safety of Appetol syrup in children suffering from non-specific anorexia - NI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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