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CTRI Number  CTRI/2025/04/085065 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to evaluate the add on effect of Ashtachoorna internally and oil massage with Lakshadi thailam over Behavioral therapy in Avoidant Restrictive Food Intake Disorder in children of age group 4 to 12 years 
Scientific Title of Study   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 Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Palshetkar Prasad Santosh 
Designation  PG Scholar, Department of Kaumarabhritya 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kaumarabhritya
Government Ayurveda College Hospital for Women and Children, Poojapura
Thiruvananthapuram
KERALA
695012
India 
Phone  9420202830  
Fax    
Email  prasadpalshetkar17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lekshmi M K 
Designation  Associate Professor, Department of Kaumarabhritya 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kaumarabhritya
Government Ayurveda College Hospital for Women and Children, Poojapura
Thiruvananthapuram
KERALA
695012
India 
Phone  9447160628  
Fax    
Email  lekshmimk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lekshmi M K 
Designation  Associate Professor, Department of Kaumarabhritya 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kaumarabhritya
Government Ayurveda College Hospital for Women and Children, Poojapura
Thiruvananthapuram
KERALA
695012
India 
Phone  9447160628  
Fax    
Email  lekshmimk@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Palshetkar Prasad Santosh 
Address  Government Ayurveda College, Hospital for Women and Children, Poojapura, Thiruvananthapuram, Kerala, India Pincode- 695012  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Palshetkar Prasad Santosh  Government Ayurveda College, Thiruvananthapuram  Department of Kaumarabhritya, Government Ayurveda College, Hospital for Women and Children, Poojapura, Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9420202830

prasadpalshetkar17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (IEC), Government Ayurveda College, Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F50||Eating disorders. Ayurveda Condition: VISHAMAGNIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Behavioral therapy Behavioral therapy will be given to all patients included in this clinical trial. A total of 16 sessions of behavioral therapy will be given to each participant in a span of 60 days.
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Ashtanghridayam, Procedure details: Oil massage over the full body with Lakshadi thailam will be done daily morning for 15 minutes before taking a bath. It will be given for a duration of 53 days, starting from 2nd week of interventional study.)
3Intervention ArmDrugClassical(1) Medicine Name: Ashtachoorna, Reference: Ashtanghridayam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Homey and Ghrita), Additional Information: Ashtachoorna will be given in the dose between 1.5 gm and 3 gm, depending on the age of the child. It will be given twice a day before meals for a duration of 60 days.
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  The children of age group 4 to 12 years satisfy DSM V criteria for Avoidant Restrictive Food Intake Disorder 
 
ExclusionCriteria 
Details  Children with congenital anomalies and genetic disorders
Children with neurodevelopmental disorders
Children with severe malnutrition
Children on prolonged medication such as steroids
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. PARDI-AR-Q (Pica, ARFID, Rumination Disorder Interview, ARFID Questionnaire).
2. To assess the changes in nutritional status with the help of anthropometric measurements with WHO AnthroPlus software
 		 0th, 31st, 61st day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To analyse changes in the Gut microbiomes (16s rRNA gene sequence analysis) in subset samples.
2. CEBQ (Child Eating Behaviour Questionnaire).
 		 0th, 61st day 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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