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CTRI Number  CTRI/2017/11/010536 [Registered on: 16/11/2017] Trial Registered Retrospectively
Last Modified On: 11/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to study the effect of Amritapraasha Ghrita in children with under nutrition 
Scientific Title of Study   An open label, two arm, randomized, active controlled clinical trial on the efficacy of amritapraasha ghrita in children with karshya (grade i and ii under nutrition) 
Trial Acronym  KAG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saranya Sivaraj 
Designation  Post graduate scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India 
Phone  9620088483  
Fax  8172256461  
Email  shalupinksss@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijayalaxmi Mallannavar MD AYU 
Designation  Associate professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax  8172256461  
Email  drvijayalaxmim@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Vijayalaxmi Mallannavar MD AYU 
Designation  Associate professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax  8172256461  
Email  drvijayalaxmim@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
Type of Sponsor  Private 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 Saranya Sivaraj  out patient department, room number 2, department of kaumarabhritya.  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA 		 9620088483
8172256461
shalupinksss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  children in the age group of 3-5 yrs with kaarshya( grade 1 & 2 under nutrition), (1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amritapraasha Ghrita   6ml of Amritapraasha Ghrita wil be given twice daily with milk for 42 days and followed up after two weeks 
Comparator Agent  normal home based diet  normal home based diet will be advised to the children and assessed after two weeks 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Subjects within age group 3-5years will be included in the study irrespective of gender, caste & religion.
2. Weight for age to be between 60 – 80 %.
3. Those parents who are ready to sign informed assent form 
 
ExclusionCriteria 
Details  1. Patient associated with acute and chronic infections, Mal-absorption syndrome and inborn errors of metabolism will be excluded from the trial based on clinical presentations. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Relief from Dourbalya
(General weakness)
2. Improvement in Kshudha(appetite), Interest in activity, Nidra (Sleep), Appearance.
3.Relief from constipation,

4. Improved Buccal pad of fat
5. Improved academic performance
 		 56 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvements in height in cm (measured using stadiometer)
2. Improvements in weight in kg (measured using standard weighing scale)
3. Improvements in chest circumference (measured using standard measuring tape)
4. Improvements in mid arm circumference (measured using standard measuring tape)
5. Head circumference. (measured using standard measuring tape)
6. Skin fold thickness (measured using skin caliper)
 		 56 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/04/2017 
Date of Study Completion (India) 27/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is an open label, two arm, randomized, active controlled clinical trial comparing the efficacy of Amritapraasha Ghrita 6ml twice daily and normal home based diet(no intervention)  in 30 patients of the age group 3-5yrs with grade 1 and 2 under nutrition. 6ml of Amritapraasha Ghrita wil be given twice daily with milk for 42 days for the study group and will be followed up after two weeks.This study will be conducted in Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India. The primary outcome measures will be increase in weight in kg(IAP Grading of malnutrition), height in cm, head circumference in cm, chest circumference in cm, mid arm circumference in cm and skin fold thickness. The secondary outcome measures will be relief from dourbalya

(general weakness), increase in kshudha(appetite), increase of interest in activity, attaining sound nidra (sleep), improvement in appearance, relief from constipation, increased buccal pad of fat, improved academic performance and improved laboratory parameters. the laboratory parameters are CBC, Hb% and serum protein. The data will be tabulated and analyzed using SPSS softwere by using appropriate statistical test like Friedman’s test, Wilcoxon’s signed rank test, chi-square test, repeated measure ANOVA, paired t and unpaired t test.


 
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