Evaluation Of Comparative Efficacy Of Ashwagandha Ghrita With Kumarkalyan Ghrita As Adjuvant Therapy To Standard Diet In The Management Of Karshya (PEM) In School Going Children: A Triple Parallel Arm Interventional Study – Protocol Article for randomized controlled trial (Preprint)
Authors: Raut Mohan , Rathi Renu , Rathi Bharat , Raut Priya 
Published: April 2024

BACKGROUND

Acharya Charaka in Ashtoninditaadhyaya mentioned eight undesirable physical appearances based on certain factors like height, body weight, total body mass, presence or absence of hair etc1. Karshya could be an organic process disorder delineated It has the potential to be linked to undernutrition in old Ayurvedic lexicons. Because Karshya is an associate apatarpanajanya vyadhi, santarpana or Brumhana Chikitsa must handle it. Brumhana refers to the healthy development of Dhatus, particularly Kapha, Mamsa, and Meda, which leads to the right development and improvement of various bodily components. Ahara and aushadha are commonly used to describe Brumhana's evolution (medicine).
When compared to Brumhana Ahara, Brumhana Aushadha yields quicker outcomes.
Food (Aahara) is one of the three sub-pillars of life as per Ayurvedic classics and Ahara Dosha (faulty dietary habits) is the main predisposing factor for this disorder among which Alpashana (reduced intake of food) and Vishamashana (false habit of intake) are especially responsible in the development of Karshya. The management of Karshya is aimed at correcting the digestive capacity and supplementing the required nutrients
Karshya is a disease in which the body never achieved weight due to a reduction in Rasadi Saptadhatu. Children are subjected to permanent bodily and mental harm. A Karshya child is underweight for his or her age, does not completely develop, and exhibits chronic undernutrition at the most important times of growth and development in childhood.
Acharya Charaka in Maharogadhyaya mentioned this as one of the vatavikara.
Undernutrition means low-weight-for-age. Stunting denotes low-height-for-age. And wasting means low-weight-for-height.
Throughout the whole life span, nutrition is a crucial pillar of human survival, health, and development. For survival, physical development, mental development, performance and productivity, health and well-being, correct diet, and nutrition are crucial from the earliest phases of fetal development at birth through infancy, childhood, adolescent, and into adulthood and old life. According to research, children's physical development and cognitive development are faster in their early years of life. By the age of four, 50% of an adult's intellectual ability has been reached, and by the age of thirteen, 92% of an adult's intellectual capacity has been reached. Malnutrition affects brain growth and development and hence future behavioral outcomes. School-age children who suffered from early childhood malnutrition have generally poorer IQ levels, cognitive function, school achievement, and greater behavioral problems than matched controls and, to a lesser extent, siblings. The disadvantages last at least until adolescence. There is no consistent evidence of a specific cognitive deficit.

OBJECTIVE

Primary objective
1.	To study the efficacy of Ashwagandha Ghrita along with a protein diet to augment the weight and IQ in school-going children of age group 5 years- 10 years age on objective and subjective criteria
2.	To study the efficacy of Kumarkalyan Ghrita along a with protein diet to augment weight and IQ in school-going children of age group 5 years -10 years age. on objective and subjective criteria
3.	To compare the efficacy of both Ghrita’s with Protein diet with respect to the objective and subjective criteria
Secondary objective
•	Improvement in laboratory indicators in Objective criteria due to the effect of Ghrita.
•	Improvement in anthropometric values of patients involved.
•	Improvement of morbidity status as compared to the past 6 months during the treatment period with the help of morbidity score (incidences of last 3 months × severity)
•	Changes in their academic performance.

METHODS

Methodology:
Study setting: Children between 5 years to 10 years of age above >25thpercentile and below <50thpercentile of weight will be enrolled for the study.
Children will be recruited for the study at Kaumarbhritya OPD, IPD of Mahatma Gandhi Ayurved College Hospital & Research Center, Salod (H) Wardha, and also school health checkup camps will be held.
Trial Design - Randomized Three-arm Single Blind Comparative Interventional Study.
Study type - Interventional
Allocation ratio - SNOSE Technique

RESULTS

Data monitoring: Six monthly reports of research work will be submitted to Ph.D. cell of DMIMS University which will include monitoring of Data.
Ethical Clearance: Clearance from the institutional ethical committee of DMIMS, Sawangi Wardha has been received vide letter no MGACHRC/IEC/Oct 2022/605
IMPLEMENTATION: primary investigator will be enrolled the patient
TIME DURATION: 180 DAYS
FOLLOW-UP PERIOD: 90th day of treatment

CONCLUSIONS

CONCLUSION: The scientific basis of interventions like Ashwagandha Ghrita Kumarkalyan Ghrita with diet alone will prove the efficacy to augment the weight and IQ in School Going Children with Karshya.

CLINICALTRIAL

Trial registration- CTRI No. CTRI/2023/03/050541 (clinical trial registry of India)
Dated – 10/03/2023