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Clinical Trials/CTRI/2024/10/075291
CTRI/2024/10/075291Not yet recruitingPhase 2/3

Evaluation of Kumarkalyana ghrita in management of underweight in children – a randomized controlled clinical trial

Dr Laxman N Zargad1 site in 1 country30 target enrollmentStarted: January 1, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
There might be a significant effect of Kumarkalyana ghrita in management of underweight in children.

Study Overview

Brief Summary

Malnutrition is the major global health problem in children which affects large numbers of children in developing countries. Under nutrition or underweight children are those who have their expected weight for age to be between (-2)SD to (-3) SD in growth chart.(1)  Nearly half of deaths among children under 5 years of age are linked to undernutrition. These mostly occur in low- and middle-income countries. The developmental, economic, social and medical impacts of the global burden of malnutrition are serious and lasting, for individuals and their families, for communities and for countries(2). As per NFHS 5 in India shows 32.1% were underweight,  35.5% were stunted & 19.3% were wasted.(3)Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.Malnutrition  can cause missing key nutrients, which can affect brain development and slower growth. Despite numerous interventions and initiatives aimed at minimizing malnutrition and mortality among children, the situation remains a major concern that requires some more action. At present, the line of treatment adopted is administering nutritional supplements, anti-helminthic drugs, etc The protein powders are the most commonly used health supplement. Its components like fibre and isolates of soya protein may lead to gastro-intestinal problems like constipation, bloating, and nausea.(4) In Ayurveda various drugs have been mentioned which have pustikar, balya, brihmana karma and can have multidimensional effect on improving child’s nutrition and health. Kumarkalyana Ghrita is one of the drug mentioned in classics which posses karmas like *pustikarand balya.(5)*Therefore, this study is taken for the management of underweight in children.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Year(s) to 6.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children fulfilling diagnostic criteria Children with normal appetite measured by score 7- 8 on hunger rate scale.

Exclusion Criteria

  • Children with weight for age more than median.
  • Children with known cases of tuberculosis, liver disorders, neurological & endocrine disorders.
  • Children who are currently using other medications like steroids etc will be excluded.
  • Children on any form of food supplements.
  • Children known with lactose intolerance.
  • Children with any development disability like Cerebral palsy , Mental retardation etc.

Outcomes

Primary Outcomes

There might be a significant effect of Kumarkalyana ghrita in management of underweight in children.

Time Frame: 0TH DAYS | 15TH DAYS | 30TH DAYS | 45TH DAYS

PRIMARY OUTCOME: Measured by changes in weight and BMI.

Time Frame: 0TH DAYS | 15TH DAYS | 30TH DAYS | 45TH DAYS

Secondary Outcomes

  • Weight(BMI)

Investigators

Sponsor
Dr Laxman N Zargad
Sponsor Class
Other [(self)]
Responsible Party
Principal Investigator
Principal Investigator

Dr Laxman N Zargad

KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka

Study Sites (1)

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