Clinical study to evaluate the immunomodulatory effect of Swarnprashan in Moderately Malnourished Children

A Randomized Double Blind Placebo control clinical study to evaluate the immunomodulatory effect of Swarnprashan in Moderately Malnourished Children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051292

Enrollment

160

Registered

2023-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E440- Moderate protein-calorie malnutrition Health Condition 2: E440- Moderate protein-calorie malnutrition

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Frequency of infections between SP vs non-SP group of children with moderate malnutrition.Timepoint: 0,6 and 12 months	—

Secondary

Measure	Time frame
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) b. Change in Serum immunoglobulin level(IgG, IgM, IgA) (time frame: baseline ,6 & 12 month) c. Improvement in reactivity of T cells to universal vaccine antigens before and after treatment (time frame: baseline ,6 & 12 month) d. Improvement in production of cytokines in the supernatant after stimulation of PBMCs (time frame: baseline ,6 & 12 month) e. Alteration in different T-cell, B-cell, NK cell, M1 and M2 macrophages populations(time frame: baseline ,6 & 12 month) f. Improvement in neutrophils functions by NETosis (time frame: baseline ,6 & 12 month) g. Adverse events: The number of children who develop undesirable gastrointestinal or extra intestinal disorders Timepoint: 0,6 and 12 months	—

Measure

Time frame

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) b. Change in Serum immunoglobulin level(IgG, IgM, IgA) (time frame: baseline ,6 & 12 month) c. Improvement in reactivity of T cells to universal vaccine antigens before and after treatment (time frame: baseline ,6 & 12 month) d. Improvement in production of cytokines in the supernatant after stimulation of PBMCs (time frame: baseline ,6 & 12 month) e. Alteration in different T-cell, B-cell, NK cell, M1 and M2 macrophages populations(time frame: baseline ,6 & 12 month) f. Improvement in neutrophils functions by NETosis (time frame: baseline ,6 & 12 month) g. Adverse events: The number of children who develop undesirable gastrointestinal or extra intestinal disorders Timepoint: 0,6 and 12 months

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Countries

India

Contacts

Public ContactVikas Agarwal

Sanjay Gandhi Postgraduate Institute of Medical Sciences

vikasagr@sgpgi.ac.in

Outcome results