| 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 |
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Type of Study
|
Ayurveda Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Development of a Millet-Based Complementary Food for Moderately Acute Malnourished Children. |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
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Source of Monetary or Material Support
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| All India Institute of Ayurveda, New Delhi, India, 110076 |
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Primary Sponsor
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| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri , Sarita vihar, 110076 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E41||Nutritional marasmus. Ayurveda Condition: KARSYAM (KEVALAVATA), |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other 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: | | 2 | Intervention Arm | Drug | Other 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 |
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Inclusion Criteria
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| 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.
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| 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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| 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.
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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)
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Secondary Outcome
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| Outcome |
TimePoints |
Changes in Hb levels
Acceptability and adherence to the porridge
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Changes in Hb levels (on 0th day - 6th week)
Acceptability and adherence to the porridge (on 0th day - 6th week)
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Target Sample Size
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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" |
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Phase of Trial
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Phase 2/ Phase 3 |
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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 |
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Estimated Duration of Trial
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Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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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. |