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CTRI Number  CTRI/2024/10/075291 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 14/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of Kumarkalyana ghrita in underweight in children  
Scientific Title of Study   Evaluation of Kumarkalyana ghrita in management of underweight in children – a randomized controlled clinical trial 
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 Laxman N Zargad  
Designation  PG Scholar 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9011165828  
Fax    
Email  zargadlaxman1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena Tonne 
Designation  Associate Professor 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  09538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Veena Tonne 
Designation  Associate Professor 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  09538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003 
 
Primary Sponsor  
Name  Dr Laxman N Zargad 
Address  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003 
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 VEENA TONNE  Kl Ayurveda Hospital  OPD no 10, Department of Kaumarbhritya KLE Shri B.M.K Ayurveda Mahavidyalaya, Belagavi Belgaum KARNATAKA
Belgaum
KARNATAKA 
9538469641

dr.veenatonne@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research On Human Subjects KAHER Shri B M Kananwadi Ayurveda Mahavidyalaya  Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E639||Nutritional deficiency, unspecified. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: KUMARAKALYANA GHRITA, Reference: BHAISHJYA RATNAVALI , Route: Oral, Dosage Form: Ghrita, Dose: 4.5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LIKE WARM MILK), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Ashwagandha ghrita , Reference: BHAISHYJA RATNAVALI BALROG ADHIRKAR 71/132, Route: Oral, Dosage Form: Ghrita, Dose: 4.5(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -LUKE WARM MILK), Additional Information: -
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children fulfilling diagnostic criteria
Children with normal appetite measured by score 7- 8 on hunger rate scale
 
 
ExclusionCriteria 
Details  Children with weight for age more than median.
Children with known cases of tuberculosis, liver disorders, neurological & endocrine disorders.
Children who are currently using other medications like steroids etc will be excluded.
Children on any form of food supplements.
Children known with lactose intolerance.
Children with any development disability like Cerebral palsy , Mental retardation etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There might be a significant effect of Kumarkalyana ghrita in management of underweight in children.
PRIMARY OUTCOME: Measured by changes in weight and BMI.
 
0TH DAYS
15TH DAYS
30TH DAYS
45TH DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Weight
BMI
Skin fold thickness
Height
Chest circumference
Mid Arm circumference
Assessment as per classical lakshanas of krishata
 
0TH DAYS
15TH DAYS
30TH DAYS
45TH DAYS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

      Malnutrition is the major global health problem in children which affects large numbers of children in developing countries. Under nutrition or underweight children are those who have their expected weight for age to be between (-2)SD to (-3) SD in growth chart.(1)  Nearly half of deaths among children under 5 years of age are linked to undernutrition. These mostly occur in low- and middle-income countries. The developmental, economic, social and medical impacts of the global burden of malnutrition are serious and lasting, for individuals and their families, for communities and for countries(2). As per NFHS 5 in India shows 32.1% were underweight,  35.5% were stunted & 19.3% were wasted.(3)Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.Malnutrition  can cause missing key nutrients, which can affect brain development and slower growth. Despite numerous interventions and initiatives aimed at minimizing malnutrition and mortality among children, the situation remains a major concern that requires some more action. At present, the line of treatment adopted is administering nutritional supplements, anti-helminthic drugs, etc The protein powders are the most commonly used health supplement. Its components like fibre and isolates of soya protein may lead to gastro-intestinal problems like constipation, bloating, and nausea.(4) In Ayurveda various drugs have been mentioned which have pustikar, balya, brihmana karma and can have multidimensional effect on improving child’s nutrition and health. Kumarkalyana Ghrita  is one of the drug mentioned in classics which posses karmas like pustikar and balya.(5) Therefore, this study is taken for the management of underweight in children.

 
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