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CTRI Number  CTRI/2025/10/095800 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Improving Nutrition in Preschool Children with Vidarkandadi Granules: A Study in Faridabad Villages 
Scientific Title of Study   Prevalence of childhood karshya (Grade I and II malnutrition)in Pre-School children across selected villages of Faridabad district and its management with Vidarikandadi Granule: An open lable,Single arm clinical study 
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 Sushil 
Designation  PG SCHOLAR 
Affiliation  All India Institute of ayurveda,sarita vihar,New delhi 110076 
Address  Room no 406 Department of Kaumarbhritya Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 South DELHI 110076 INDIA

South
DELHI
110076
India 
Phone  9802141476  
Fax    
Email  saharan1546@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajagoala S 
Designation  Additional Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room no 404 Department of Kaumarbhritya Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 South DELHI 110076 INDIA

South
DELHI
110076
India 
Phone  7600902564  
Fax    
Email  srajagopala@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajagoala S 
Designation  Additional Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room no 404 Department of Kaumarbhritya Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 South DELHI 110076 INDIA

South
DELHI
110076
India 
Phone  7600902564  
Fax    
Email  srajagopala@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF AYURVEDA 
 
Primary Sponsor  
Name  All india institute of ayurveda 
Address  All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 South DELHI 110076 
Type of Sponsor  Government medical college 
 
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 Sushil  All india institute of ayurveda  room no 406 kaumarbhrtiya department
South
DELHI 		 09802141476

saharan1546@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:Z685||Body mass index (BMI) pediatric. Ayurveda Condition: KARSHNYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: VIDARIKANDADI GRANULES, Reference: YOGA RATNAKAR, Route: Oral, Dosage Form: Khanda /Granules, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Childrens of age group (1-5 years) of either sex, irrespective of caste, religion and socioeconomic status.
Weight of child less than expected as per the age i.e.grade 1 (71-80%) and grade 2 (61- 70%) according to IAP classification of malnutrition.
Parents giving consent to participate in the study
 
 
ExclusionCriteria 
Details  Patients not willing to participate in the study.
Children having celiac disease, malabsorption syndrome, metabolic error, chromosomal disease.
Children suffering from any chronic illness, hereditary diseases and malignancies.
According to IAP classification more than 80 % (normal) and less than 61 % (nutritional grade III – IV) were excluded.
Patient taking antiepileptic drugs or steroids.
Children having presence of edema was excluded even if the weight of them is 60-80% (Kwashiorkor patients).
Children with neurobehavioral disorders like ADHD, autism etc.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Childhood Karshya Grade I & II Malnutrition- The proportion of PreSchool children in the selected villages who meet the diagnostic criteria for Grade I or Grade II malnutrition, based on anthropometric indices such as weight-for-age and BMI-for-age, compared against IAP standards
Improvement in anthropometric parameters weight, height, BMI, MUAC,SFT, after administration of Vidarikandadi Granules over the defined study period in children diagnosed with Childhood Karshya 		 0, 30, 60, 90 day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in signs and symptoms of Karshya such as Daurbalya weakness, Agnimandya poor digestion, Panduta pallor, and Shrama fatigue, as assessed by subjective parameters before and after treatment  0, 30, 60, 90 day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 1 
Date of First Enrollment (India)   01/11/2025 
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="0"
Months="3"
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  

The study focuses on the prevalence and management of Childhood Karshya, defined as Grade I and II malnutrition, in pre school children of Faridabad district. The study combines a survey and an interventional trial using Vidarikandadi Granules, an Ayurvedic formulation known for nourishing and strengthening properties. The survey will cover 433 children aged 1 to 5 years through cluster sampling in Anganwadi centres, while the intervention arm will include 50 children diagnosed with Grade I and II malnutrition, given Vidarikandadi Granules for 60 days with follow up of 30 days. Dosage is age adjusted, ranging from 2 g BD at 1 year to 7 g BD at 5 years. Primary objectives are to estimate prevalence rates and evaluate improvements in weight, height, BMI, mid upper arm circumference and skinfold thickness. Secondary objectives include assessing symptoms such as weakness, loss of appetite, fatigue, and developmental lag. The budget sanctioned is Rs 60000, covering drug preparation, packaging, and investigations. Compliance protocols, informed consent, adverse event reporting, and ethics approvals from IRB and IEC are in place. Previous studies cited support Ayurvedic approaches for childhood malnutrition. This study aims to integrate Ayurveda into community based child health strategies.

 
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