A study on the effect of Ayurvedic complementary food.

Phase 3

Not yet recruiting

• Conditions: Children at risk of malnutrition.

• Registration Number: CTRI/2023/06/053488

Brief Summary

The study is designed as a two-arm randomizedcontrolled parallel clinical trial without blinding. 110 children at risk of malnutrition aged 6 to 12 monthswill be selected from the OPD and Immunisation unit of Govt. Ayurveda CollegeHospital for Women and children Poojappura Thiruvananthapuram. They will beassigned to the study group and control group by using the simple randomizationtechnique. Priyalamajjadi yoga (*PMY)*will be prepared in granulated form. The phytochemical parameters of the formulation *PMY* will bedone as per the ‘General guidelines for drug development of Ayurvedicformulations’published by CCRAS. The dose of the same will be calculated by determining its nutritivevalue by Recommended Dietary Allowance (RDA) of the concerned age group as perstandard methods with the help of a nutritional expert in an approvedlaboratory and also considering the inputs from Ayurvedic treatises.

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-06
• Study Start: 2023-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.
1.Weight	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.
2.Length	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.
3.Head circumference	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.
4.Mid upper arm circumference	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.
5.Chest circumference	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.
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 Measures

Name	Time	Method
Biochemical parameters	Assessments of both the clusters in each group will be done before, during and after the study period of 2 months.

Trial Locations

Locations (1)

Government Ayurveda college, Thiruvananthapuram; 🇮🇳 Thiruvananthapuram, KERALA, India

Government Ayurveda college, Thiruvananthapuram

🇮🇳Thiruvananthapuram, KERALA, India

Dr Lekshmi M K

Principal investigator

9447160628

lekshmimk@gmail.com