Clinical study to evaluate the immunomodulatory effect of Swarnprashan in Moderately Malnourished Childre
- Conditions
- Health Condition 1: E440- Moderate protein-calorie malnutritionHealth Condition 2: E440- Moderate protein-calorie malnutrition
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a)Malnourished children of age between 5-10 years fulfilling criteria for moderate malnutrition (MM) defined as weight-for- age between -3 and -2 z-scores below the median of the WHO child growth standards.
b)Who are willing to give informed Consent of the parents/ guardian and assent of the Children for their participation in the study
a)Children having any acute infection
b)Children with chronic illnesses that may affect growth {cardiac disease, renal disease, tuberculosis (chronic cough, history of contact with an adult with chronic cough, poor growth, chest infection not responding to antibiotics) liver disease, HIV/AIDS}
c)Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
d)Children with neurological diseases eg. Cerebral palsy etc
e)Whose parents are likely to migrate out of the locality over next one year at the time of screening
f)Any other condition that the investigator thinks may jeopardise the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of infections between SP vs non-SP group of children with moderate malnutrition.Timepoint: 0,6 and 12 months
- Secondary Outcome Measures
Name Time Method a.Recovery from Moderate malnutrition in terms of improvement in anthropometric parameters. (height, weight, BMI, growth as per growth charts) (time frame: baseline and monthly once upto 12 months) <br/ ><br>b.Change in Serum immunoglobulin level(IgG, IgM, IgA) (time frame: baseline ,6 & 12 month) <br/ ><br>c.Improvement in reactivity of T cells to universal vaccine antigens before and after treatment (time frame: baseline ,6 & 12 month) <br/ ><br>d.Improvement in production of cytokines in the supernatant after stimulation of PBMCs (time frame: baseline ,6 & 12 month) <br/ ><br>e.Alteration in different T-cell, B-cell, NK cell, M1 and M2 macrophages populations(time frame: baseline ,6 & 12 month) <br/ ><br>f.Improvement in neutrophils functions by NETosis (time frame: baseline ,6 & 12 month) <br/ ><br>g.Adverse events: The number of children who develop undesirable gastrointestinal or extra intestinal disorders <br/ ><br>Timepoint: 0,6 and 12 months