Evaluation Of Balamoola Granules In Management Of Underweight In School Going Children -a randomised controlled clinical trial

KLE Ayurveda Hospital1 site in 1 country30 target enrollmentStarted: August 10, 2024Last updated: July 13, 2024

Trial Snapshot

Phase: Phase 2/3
Status: Not yet recruiting
Sponsor
Enrollment: 30
Locations: 1
Primary Endpoint: THERE MIGHT BE SIGNIFICANT EFFECT OF BALAMOOLA GRANULES IN UNDERWEIGHT CHILDREN

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

Malnutrition is the main global health problem of 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) to (-3) SD in growth chart.

In 2021, different studies conducted in India on assessment of nutritional status of primary school children shows that the prevalence rate of underweight is between 18.33% to 50.05%. As per NFHS 5 in India shows 35.7% were underweight, 38.4% were stunted & 21% were wasted.More than 200 million school age children are malnourished in India.

School going age is very significant because this is the main period of life to make the body store nutrients. Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.

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.

Therefore in Ayurveda various drugs have been mentioned with pustikara, balya, brhmana karma which can have multidimensional effect on childâ€™s health.

Balamoola is one of the drug mentioned in classics which posses karmas like pustikara, brmhana and balya.

Study Design

Study Type: Interventional
Allocation: Randomized
Masking: None

Eligibility Criteria

Ages: 6.00 Year(s) to 10.00 Year(s) (—)
Sex: All

Inclusion Criteria

•Malnutrition is the main global health problem of 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) to (-3) SD in growth chart.(1) In 2021, different studies conducted in India on assessment of nutritional status of primary school children shows that the prevalence rate of underweight is between 18.33% to 50.05%.
•As per NFHS 5 in India shows 35.7% were underweight, 38.4% were stunted & 21% were wasted.(2) More than 200 million school age children are malnourished in India.
•School going age is very significant because this is the main period of life to make the body store nutrients.
•Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.
•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(3).
•Therefore in Ayurveda various drugs have been mentioned with pustikara, balya, brhmana karma which can have multidimensional effect on childâ€™s health.
•Balamoola is one of the drug mentioned in classics which posses karmas like pustikara(4) , brmhana(5) and balya.

Exclusion Criteria

•Malnutrition is the main global health problem of 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) to (-3) SD in growth chart.(1) In 2021, different studies conducted in India on assessment of nutritional status of primary school children shows that the prevalence rate of underweight is between 18.33% to 50.05%.
•As per NFHS 5 in India shows 35.7% were underweight, 38.4% were stunted & 21% were wasted.(2) More than 200 million school age children are malnourished in India.
•School going age is very significant because this is the main period of life to make the body store nutrients.
•Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.
•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(3).
•Therefore in Ayurveda various drugs have been mentioned with pustikara, balya, brhmana karma which can have multidimensional effect on childâ€™s health.
•Balamoola is one of the drug mentioned in classics which posses karmas like pustikara(4) , brmhana(5) and balya.