Evaluation of efficacy and safety of Aptivate syrup in children with non-specific anorexia – An open label, randomized, comparative, multicentric, interventional, prospective clinical study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 1. Change in the clinical symptoms of anorexia measured using the total effective rate (TER).
研究概览
简要总结
It is an open label, randomized, comparative, multicentric, interventional, prospective clinical study to evaluate efficacy and safety of Aptivate syrup in children with non-specific anorexia. The study will be carried out in 3 to 4 centres in India. As per computer generated list, Subjects will be randomized either to Aptivate Syrup Group or non-user group in 1:1 ratio. Participants in Aptivate syrup group will be asked to take Aptivate syrup in a dose of 5 ml twice daily before food for a period of 6 months. Participants in this group will not be given any intervention but will be followed up for a period of 6 months. Primary objectives of the study will be to assess change in the clinical symptoms of anorexia measured using the total effective rate (TER) and change in eating behaviour using Child Eating Behaviour Questionnaire (CEBQ). The secondary objectives of the study will be to assess change in appetite assessed using VAS, change in appetite assessed using picture-based appetite assessment (PBAA) tool, change in desire to eat, quantity of food intake, left over in the plate, number of meals taken per day and range of food taken on VAS (based on subject diary), change in anthropometric measurements i.e. height, weight, head circumference, mid arm circumference, body mass index (BMI), Waist circumference, Hip Circumference, Waist: HIP ratio, and skinfold thickness, change in abdominal pain (VAS), bowel habits, abdominal fullness, flatulence, over all digestion (VAS), Sleep, satiety, fatigue, general energy levels and physical activity using VAS, overall sensorial feeling on consumption of study drugs, drowsiness or sedation due to study drugs, Change in memory on Children Memory Questionnaire (CMQ), change in incidence of infections, and allergy related disorders (No of episodes, duration of episodes, no of subjects), change in onset of action and duration of action of drugs with respect to its appetite stimulating activity, global assessment of overall change to be assessed by Physician and Subject and adverse events randomization visit (Day 0), visit I (Day 30), visit II (Day 60), visit III (Day 90), visit IV (Day 120), visit V (Day 150), visit VI (Day 180)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with Poor Appetite and Digestion without any underlying pathological condition without any significant weight loss over the last 3 months
- •Children having Eating Disorders falling in the criteria of.
- •Unspecified Feeding or Eating Disorders as per DSM 5 TR criteria: (This category applies to presentations in which symptoms characteristic of a feeding and eating disorder that cause clinically significant distress or impairment in social, occupational, or other important areas of functioning predominate but do not meet the full criteria for any of the disorders in the feeding and eating disorders diagnostic class. The unspecified feeding or eating disorder category is used in situations in which the clinician chooses not to specify the reason that the criteria are not met for a specific feeding and eating disorder and includes presentations in which there is insufficient information to make a more specific diagnosis.
排除标准
- •Children with chronic illnesses and taking medications for the same or congenital abnormalities
- •Children who are currently taking any medications for appetite stimulation or digestive disorders
- •Children who have used any investigational product 1 month prior to screening in the present study
- •Children taking systemic antibiotics for any infection
- •Children with known metabolic and/or endocrine disorder/s
- •Children with any type of known GI tract disorder (including mal-absorption syndrome, etc.)
- •Children with known Liver and Renal disorders
- •Children with known hypersensitivity to herbal ingredients used in the study product or in general to any herbal product
- •Any other condition due to which children are deemed to be unsuitable by investigator for reason(s) not specifically stated in the exclusion criteria.
结局指标
主要结局
1. Change in the clinical symptoms of anorexia measured using the total effective rate (TER).
时间窗: Screening Visit (Up to 5 days), Randomization Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120), Visit V (Day 150), Visit VI (Day 180)
2. Change in eating behavior using Child Eating Behavior Questionnaire (CEBQ)
时间窗: Screening Visit (Up to 5 days), Randomization Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120), Visit V (Day 150), Visit VI (Day 180)
次要结局
- 1. Change in appetite assessed using VAS(2. Change in appetite assessed using picture based appetite assessment tool)
研究者
Dr Shishir P Pande
Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi, Nashik