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
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 1. PARDI-AR-Q (Pica, ARFID, Rumination Disorder Interview, ARFID Questionnaire).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The children of age group 4 to 12 years satisfy DSM V criteria for Avoidant Restrictive Food Intake Disorder.
Exclusion Criteria
- •Children with congenital anomalies and genetic disorders Children with neurodevelopmental disorders Children with severe malnutrition Children on prolonged medication such as steroids.
Outcomes
Primary Outcomes
1. PARDI-AR-Q (Pica, ARFID, Rumination Disorder Interview, ARFID Questionnaire).
Time Frame: 0th, 31st, 61st day
2. To assess the changes in nutritional status with the help of anthropometric measurements with WHO AnthroPlus software
Time Frame: 0th, 31st, 61st day
Secondary Outcomes
- 1. To analyse changes in the Gut microbiomes (16s rRNA gene sequence analysis) in subset samples.(2. CEBQ (Child Eating Behaviour Questionnaire).)
Investigators
Dr Palshetkar Prasad Santosh
Government Ayurveda College, Thiruvananthapuram