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CTRI Number  CTRI/2022/04/041559 [Registered on: 01/04/2022] Trial Registered Prospectively
Last Modified On: 31/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Malnutrition in children 
Scientific Title of Study   A Community Based Study to Evaluate the Efficacy of Priyalaadi Modaka in the Management of Karshya with special reference to Malnutrition in Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kishan Gopal Choudhary 
Designation  M.D (Ayu) Scholar 
Affiliation  National Institute of Ayurveda 
Address  National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur - 302002
OPD no. 5, Department of Kaumarbhritya, Ground Floor, National Institute of Ayurveda, Near Jorawar Singh Gate, Amer Road, Jaipur – 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9460228368  
Fax    
Email  dr.kgchoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nisha Kumari Ojha 
Designation  M.D (Ay.), Ph.D (Ay.), PDCR, B.Sc, Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur - 302002
OPD no. 5, Department of Kaumarbhritya, Ground Floor, National Institute of Ayurveda, Near Jorawar Singh Gate, Amer Road, Jaipur – 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishan Gopal Choudhary 
Designation  M.D (Ayu) Scholar 
Affiliation  National Institute of Ayurveda 
Address  National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur - 302002
OPD no. 5, Department of Kaumarbhritya, Ground Floor, National Institute of Ayurveda, Near Jorawar Singh Gate, Amer Road, Jaipur – 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9460228368  
Fax    
Email  dr.kgchoudhary@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan - 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur - 302002 
Type of Sponsor  Research institution and hospital 
 
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 Kishan Gopal Choudhary  National Institute of Ayurveda Campus Hospital  OPD No 5, Kaumarbhritya Department, Ground Floor, National Institute of Ayurveda, Near Jorawar Singh Gate, Amer Road, Jaipur - 302002
Jaipur
RAJASTHAN 		 9460228368

dr.kgchoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E441||Mild protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Priyaaladi Modak, Reference: Gadnigrah 11/81, Route: Oral, Dosage Form: Modaka , Dose: 40(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Comparator Arm (Non Ayurveda)-Health education material and Study tools (Dietary Rehabilitation)Health education materials which included pamphlets and posters will be prepared in Hindi language by the Principal investigator. It will be developed based on the Manual of Dietary Guidelines for Indians published by National Institute of Nutrition (ICMR), Guidelines for optimal infant and young child feeding practice by National Health Mission and IEC materials published by Department of IEC, Rajasthan Health Mission.
 
Inclusion Criteria  
Age From  13.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  1. Children aged 13-60 months of either sex with no major medical complication.
2. Mother and care taker trainable to provide home based diet. 
3. Parents or caretaker willing to participate in the clinical trial. 
4. Not planning to leave the study area for the coming 04 months. 
 
ExclusionCriteria 
Details  1. Children suffering from severe malnutrition, who need hospitalization.
2. Tuberculosis, Cerebral palsy, Congenital heart diseases, Known metabolic
disorders, Known mal-absorption syndromes, Chromosomal malformations,
Renal or hepatic disorders.
3. Caretakers not willing to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in Weight.  Baseline, 14thday, 28th day, 42th day and 56th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in MUAC, Skinfold thickness and BMI.  Baseline, 14thday, 28th day, 42th day and 56th day. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 
Date of First Enrollment (India)   11/04/2022 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
PURPOSE :
1. To mitigate and treat malnutrition in children.
2. To evaluate the effect of Priyaladi Modaka in the management
of  Karshya with special reference to malnutrition in children.
3. To assess the prevalence of malnutrition in the study area. 
4. To identify the correlations of malnutrition in the study
population.

NEED OD STUDY: Despite the status, 14 per cent of India’s
population is undernourished. A recent report reveals that in
Rajasthan 36.7% of children under the age of five are underweight, 39.1% are stunted and 23.0% are wasted. But, still
there is no satisfactory solution and management for malnutrition
and it is the need of the time to look into the alternative systems
for the management.

NULL HYPOTHESIS (H 0 ) :
There is no difference in effect of dietary guideline alone and
with Priyalaadi Modaka in the management of Karshya with
special reference to malnutrition in children.

ALTERNATE HYPOTHESIS (H 1 ):
If the null hypothesis is rejected alternative hypothesis will be
accepted i.e. Dietary guideline along with Priyalaadi Modaka
has significant role in the management of Karshya with special
reference to malnutrition in children.
 
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