Health Condition 1: E440- Moderate protein-calorie malnutrition
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences (CCRAS)
Eligibility
Inclusion criteria
Inclusion criteria: i. Students studying in the selected EMR School of age 10-18 years of either gender diagnosed as having moderate malnutrition as per WHO Z Score criteria (BMI for Age Z Score) ii. Students who had no intention of leaving the schools until the end of the study will be included in this study. iii. Child Assent and Parents/ gaurdian willing to provide a written informed consent form for the participation of their children
Exclusion criteria
Exclusion criteria: • School students who will not be able to respond to interview and who have physical disability including deformity such as kyphosis scoliosis and limb deformity which prevents standing erect for anthropometric measurement. • Students known as having pitting edema. • Known cases having digestion and absorption diseases that affect ingestion gastrointestinal motility and or protein catabolism viz gastroesophageal reflux disease irritable bowel syndrome gastroparesis functional dyspepsia cystinuria celiac and Crohns disease etc. • Known cases of underlying chronic diseases that may affect growth such as cardiac renal tuberculosis liver disease HIV or AIDS neurological or hereditary disease. • School students who are known cases of acute and chronic systemic diseases such as diabetes mellitus hypertension psychiatric hormonal illness etc • Child with congenital abnormalities needing medical or surgical intervention • Students on medications which interfere with study outcome measurements. • Any other condition that the investigator considers may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i.The proportion of participants attaining a change in BAZ as per WHO Child Growth Standards, a change in weight and the Recovery rate (number of malnourished children recovered divided by the total number of malnourished children)Timepoint: [Time frame: at baseline, and at the end of 3rd month and 6th month] | — |
Secondary
| Measure | Time frame |
|---|---|
| ii. Assessment of the tolerability through reported incidence of treatment-emergent adverse events and serious adverse eventsTimepoint: at baseline, and at the end of 3rd month and 6th month;iii. Assessment of treatment adherence through self-reported compliance log and used medication containers/stripsTimepoint: at baseline, and at the end of 3rd month and 6th month;iv. Proportion of participants who withdrew/dropped out from the study due to adverse events and/or poor tolerabilityTimepoint: at baseline, and at the end of 3rd month and 6th month | — |
Countries
India
Contacts
Public ContactDr Renu Singh
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed