Non-randomized controlled clinical trial on the add on effect of Ashtachoorna internally and abhyanga with Lakshadi thailam over behavioral therapy in Avoidant Restrictive Food Intake Disorder ARFID in children of age group 4-12 years
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. PARDI-AR-Q (Pica, ARFID, Rumination Disorder Interview, ARFID Questionnaire).
研究概览
简要总结
Children with the age group of 4-12 years satisfying DSM-V criteria for diagnosis of ARFID will be selected for the study from the OP Department Balaroga of Govt. Ayurveda College Hospital for Women and Children, Poojappura. The participants will be allocated by consecutive sampling into study and control group. Informed consent will be taken from the parents of the selected subjects in study and control group. History and clinical evaluation will be noted as in the case proforma. The study group will receive the intervention Ashtachoorna internally and Abhyangam with Lakshadi thailam along with Behavioral therapy. The control group in this study will receive Behavioral therapy only. For clinical evaluation data regarding the objective assessment tools, and anthropometric measurements will be assessed before and after intervention. A stool sample will be taken from a feasible subset of the study group consisting of children with a substantial score (>16) on the PARDI-AR-Q scale for gut microbiome analysis both before and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •The children of age group 4 to 12 years satisfy DSM V criteria for Avoidant Restrictive Food Intake Disorder.
排除标准
- •Children with congenital anomalies and genetic disorders Children with neurodevelopmental disorders Children with severe malnutrition Children on prolonged medication such as steroids.
结局指标
主要结局
1. PARDI-AR-Q (Pica, ARFID, Rumination Disorder Interview, ARFID Questionnaire).
时间窗: 0th, 31st, 61st day
2. To assess the changes in nutritional status with the help of anthropometric measurements with WHO AnthroPlus software
时间窗: 0th, 31st, 61st day
次要结局
- 1. To analyse changes in the Gut microbiomes (16s rRNA gene sequence analysis) in subset samples.(2. CEBQ (Child Eating Behaviour Questionnaire).)
研究者
Dr Palshetkar Prasad Santosh
Government Ayurveda College, Thiruvananthapuram