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CTRI Number  CTRI/2025/04/084943 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Development of a Millet-Based Complementary Food for Moderately Acute Malnourished Children. 
Scientific Title of Study   Development of Fortified Ready to eat (RTE) Sanwa (Echinochloa frumentacea Roxb.) based complementary food and evaluation of its efficacy on Moderate Acute Malnourished (MAM) children aged 6-24 months: An Open-Label Double Arm Randomized Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Bhandari 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  4th floor academic block, Department of Kaumarabhritya All India Institute of Ayurveda, Gautampuri , Sarita vihar, 110076

South
DELHI
110076
India 
Phone  07533805323  
Fax    
Email  shwetabhandari332@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahapatra Arun Kumar 
Designation  Associate Professor 
Affiliation  All India institute of Ayurveda, New Delhi 
Address  Department of Kaumarabhritya , All India institute of Ayurveda, New Delhi, Sarita Vihar

South
DELHI
110076
India 
Phone  8506821947  
Fax    
Email  ayuarun@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajagopala S 
Designation  Additional Professor 
Affiliation  All India Institue of ayurveda, New Delhi 
Address  Department of Kaumarabhritya , All India institute of Ayurveda, New Delhi, Sarita Vihar

South
DELHI
110076
India 
Phone  7600902564  
Fax    
Email  srajagopala@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, New Delhi, India, 110076 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  All India Institute of Ayurveda, Gautampuri , Sarita vihar, 110076 
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 Shweta Bhandari  All India Institute of Ayurveda, New Delhi  OPD 208, Second floor, Kaumarabhritya department, Hospital block, All India Institute of Ayurveda, Gautampuri , Sarita vihar, 110076
South
DELHI 
07533805323

shwetabhandari332@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee All India Institute of ayurveda New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E41||Nutritional marasmus. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Sanwa porridge, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information:
2Intervention ArmDrugOther than Classical(1) Medicine Name: Sanwa porridge with trikatu fortification , Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: Final dose of drug will be calculated after the product develeopment as per caloric requirement of the infant
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  Full term (gestational age equal or over 37 weeks.
Age 6-24 months.
Diagnosed with moderate acute malnutrition based on WHO criteria.
Able to consume study food.
No known food allergy.
Feeding by mouth with human milk or formula/ top feed.



 
 
ExclusionCriteria 
Details  Pre-term or small-for-gestational-age infants
Children suffering from severe acute malnutrition.
Infants having conditions that would affect normal growth;
Not willing to feed the complementary food provided;
- Antibiotics exposure during delivery or from birth to 5 months of life; multiple births.
- Presence of any comorbidity including prematurity.
- The children with congenital anomalies and infectious diseases such as upper/lower respiratory tract illness, urinary tract infections, and unable to swallow complementary foods.
- Children suffering from any systemic illness.
- Parents not willing to participate in the study
 
 
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 
Improvement in anthropometric indices (weight, length/height, Mid upper arm circumference, chest circumference) as Per IAP.
Improvement in weight for height z score.
 
Improvement in anthropometric indices (weight, length/height, Mid upper arm circumference, chest circumference) as Per IAP.(assessment on 0th day – 6th week- 12th week)
Improvement in weight for height z score.(assessment on 0th day – 6th week- 12th week)
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Hb levels
Acceptability and adherence to the porridge
 
Changes in Hb levels (on 0th day - 6th week)
Acceptability and adherence to the porridge (on 0th day - 6th week)
 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   30/04/2025 
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="1"
Months="6"
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  

The complementary feeding period is generally associated with considerable growth faltering in low-income populations. In developing countries, complementary foods are deficient in both macronutrients and micronutrients. Coupled with a high burden of infections during the complementary feeding period are major underlying causes of child malnutrition.WHO/UNICEF have emphasized the first 1000 days of life i.e., the 270 days in-utero and the first two years after birth as the critical window period for nutritional interventions. In case of any growth faltering or deficiencies of micronutrients, it is very difficult to reverse them after 2 years of age. It is a period of rapid growth and neurodevelopment, high nutritional requirements, and high sensitivity to programming effects and, as a consequence, is a time of great vulnerability. Failure to provide sufficient calories and key nutrients during this critical period may result in stunting and lifelong deficits in brain function. In Ayurveda, Sthanya apananyana vidhi (withdrawal of breastfeeding) and the introduction of fruits or semisolid food as Phalaprashana- Annaprashana vidhi are already mentioned. Acharya Kashyapa first describes the supplementary feed at 6th month of life. No other author has described Phalaprashana. The first cereal feed was described in 6th month of age by Acharya Sushrutha and Vagbhatta. Cereal feed is prescribed at 10th month by Kashyapa -Dantha jatha i.e., after teeth eruption. Vagbhatta accepted this opinion of Annaprashana after the eruption of teeth but during 6th month of age. Cereals form a significant portion of the Indian diet. They are an important source of iron, proteins, carbs, energy, and a certain quantity of fat. The Kumaon Hills residents in Northern India depend mainly on home-cooked food. Millet is a common crop in the Kumaon Mountain region of northern India. In Uttarakhand, people have long used Sanwa (Echinochloa frumentacea Roxb.), as a supplementary diet. It is a short-duration crop that can grow in adverse environmental conditions. It contains a rich source of protein, carbohydrates, fiber, and, most notably, micronutrients like iron (Fe) and zinc (Zn) which are related to numerous health benefits. Fortification of commonly used food vehicles provides an opportunity for increasing nutrient intake during infancy and has the potential to improve growth. In this study, the formulated infant food will be fortified with Trikatu choorna due to its Deepan Property, which enhances the bioavailability of the micronutrients.

Due to financial constraints and lack of awareness, many low-income families in our country are unable to access commercial infant food products. This has led to an increasing focus on developing nutritious weaning foods using locally available ingredients in many developing countries. Various texts in Ayurveda give formulas and foods for the development of the child. Ayurvedic herbs can therefore be incorporated in weaning food formulas. The present study aimed to develop weaning food based on Sanwa (Echinochloa frumentacea Roxb.) and fortified with Ayurvedic Herb combitation Trikatu choorna. The formulated mixture will be standardized to ascertain the correct proportion of ingredients and the resultant product will be subjected to sensory analysis. Currently, Ayurved-based supplementary foods are not readily available in the local market. This highlights the need for developing an affordable Ayurvedic infant food product, utilizing locally sourced, indigenous ingredients with minimal processing.

1.     Aims and Objective

a.      Primary objective-

To develop and standardize a Ready to Eat (RTE) Sanwa (Echinochloa frumentacea Roxb.) porridge fortified with Trikatu choorna.

To evaluate the effect of Sanwa (Echinochloa frumentacea Roxb.) porridge fortified with Trikatu choorna in anthropometric (weight, Length, Chest Circumference & Mid Upper Arm Circumference) indices of Moderate Acute Malnourished (MAM) children aged 6 months to 24 months.

a.      Secondary Objective –

 Collect Data on Traditional complementary feeding practices on Sanwa (Echinochloa frumentacea Roxb.).

 To evaluate the safety and acceptability of the Sanwa (Echinochloa frumentacea Roxb.) porridge among infants.

To evaluate the nutritional values of porridge prepared with Sanwa (Echinochloa frumentacea Roxb.).

To assess the impact on the Hb level.

Feeding Intervention-

Each child of 6-8 months in the study group will receive 50g (200 kcal daily) 9-11 months 70g (300 kcal/day) and 12- 24 months 100g (550 kcal/day) of study food per day for six weeks. Five hundred grams are supplied to mothers/caregivers every two weeks. The final dose of the food studied will be decided after the nutritional analysis of the product. Mothers will be instructed to prepare and feed the study foods a minimum of two times/day in addition to other family foods. At the bi-weekly visits, study foods left over from the previous visit were weighed and recorded. Except for the porridge dietary counselling as per ayurveda in both groups will be given. Adherence to study foods was determined as the disappearance rate of study foods supplied to infants during the study period. 

 
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