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CTRI Number  CTRI/2023/06/053488 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on the effect of Ayurvedic complementary food. 
Scientific Title of Study   An open label randomised controlled trial on the effect of a standardized Ayurvedic nutraceutical in the growth and development of children at risk of malnutrition aged 6 to 12 months. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lekshmi M K 
Designation  Associate professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kaumarabhritya, Government Ayurveda Collwgw hospital for women and children, Poojappura, Thiruvanananthapuram

Thiruvananthapuram
KERALA
695014
India 
Phone  9447160628  
Fax    
Email  lekshmimk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheba M D 
Designation  Principal 
Affiliation  Kerala University of health sciences 
Address  Ahalia Ayurveda medical college, Palakkad

Palakkad
KERALA
678557
India 
Phone  9447745450  
Fax    
Email  drshebasunil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lekshmi M K 
Designation  Associate professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kaumarabhritya, Government Ayurveda College hospital for women and children, Poojappura, Thiruvananthapuram

Thiruvananthapuram
KERALA
695012
India 
Phone  9447160628  
Fax    
Email  lekshmimk@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college hospital for women and children,Poojappura, Thiruvananthapuram. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Lekshmi M K  Government Ayurveda college, Thiruvananthapuram  Department of Kaumarabhritya, Government Ayurveda college W & C hospital, Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9447160628

lekshmimk@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 
Healthy Human Volunteers  Children at risk of malnutrition. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Priyalamajjadi, Reference: Ashtangahridaya, Route: Oral, Dosage Form: Modaka , Dose: 15(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
2Comparator Arm (Non Ayurveda)-Control groupStandard diet chart
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details  1. Children at risk of malnutrition who has started weaning.
2. Children at risk of malnutrition of both sexes aged 6 to 12 months and receiving breast milk.
 
 
ExclusionCriteria 
Details  1. Nutritional deficiencies associated with pathological conditions.
2. Children with overweight.
3. Children with congenital anomalies, metabolic disorders, neurodevelopmental problems etc.
4. Children with known acute or chronic illness

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in
1. Weight
2. Length
3. Head circumference
4. Mid upper arm circumference
5. Chest circumference
6. Development assessed by TDSC chart
 		 Assessments of both the clusters in each group will be done before, during and after the study period of 2 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Biochemical parameters  Assessments of both the clusters in each group will be done before, during and after the study period of 2 months. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   15/06/2023 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study is designed as a two-arm randomized controlled parallel clinical trial without blinding. 110 children at risk of malnutrition aged 6 to 12 months will be selected from the OPD and Immunisation unit of Govt. Ayurveda College Hospital for Women and children Poojappura Thiruvananthapuram. They will be assigned to the study group and control group by using the simple randomization technique. Priyalamajjadi yoga (PMY) will be prepared in granulated form. The phytochemical parameters of the formulation PMY will be done as per the ‘General guidelines for drug development of Ayurvedic formulations’  published by CCRAS. The dose of the same will be calculated by determining its nutritive value by Recommended Dietary Allowance (RDA) of the concerned age group as per standard methods with the help of a nutritional expert in an approved laboratory and also considering the inputs from Ayurvedic treatises.

The growth velocity of children aged 6-9 months is different from children aged 10-12 months. Hence the dose of the formulation and dietary advice is different for each of the above groups. Therefore the study group and the control group will be again divided into two clusters, and the dose of the formulation will be calculated accordingly. Standard dietary charts will be provided for both groups. Changes in anthropometric parameters specified for the age will be collected through the case-proforma and WHO anthropometric software. Evaluation will be done before and after two months of intervention. The data will be consolidated and statistically evaluated using appropriate statistical tools. 

 

 
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