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CTRI Number  CTRI/2024/09/073317 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Analytical study 
Study Design  Other 
Public Title of Study   Nutritional Wholesome biscuit preparation  
Scientific Title of Study   Development and evaluation of nithya sevaniya wholesome biscuits 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Asath bharathy p 
Designation  PG Scholar 
Affiliation  KLE Academy of Higher Education and Research - University 
Address  Dept of RSBK KLEU Shri BMK Ayurveda mahavidyalaya and hospital, Shahapur, Belagavi
KLEU Shri BMK Ayurveda mahavidyalaya and hospital, Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  6380253100  
Fax    
Email  asathbharathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeshwari V Kamat 
Designation  Professor, Dept of Rasashastra and Bhaishajya kalpana 
Affiliation  KLE Academy of higher education and research center 
Address  Dept of RSBK KLEU shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9449107481  
Fax    
Email  drrajeshwarikamat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeshwari V Kamat 
Designation  Professor, Dept of Rasashastra and Bhaishajya kalpana 
Affiliation  KLE Academy of higher education and research center 
Address  Dept of RSBK KLEU shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9449107481  
Fax    
Email  drrajeshwarikamat@gmail.com  
 
Source of Monetary or Material Support  
KLEU shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi, KARNATAKA 590003. 
 
Primary Sponsor  
Name  Dr Asath bharathy p 
Address  Dept of RSBK KLEU shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi 
Type of Sponsor  Other [(SELF) in partial fulfilment of the requirement for the degree of MD ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asath bharathy p  KLEU shri BMK Ayurveda Mahavidyalaya  Room no 33,Dept of RSBK, Manthana block,KLEU shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi, KARNATAKA
Belgaum
KARNATAKA 
6380253100

asathbharathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee for research on human subjects KAHERS Shri BMK Ayurvedha mahavidhyalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy person 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Human subjects involved in the study for sensory evaluation purpose will be explained about the preparation of the biscuits for convenience  
 
ExclusionCriteria 
Details  Age below 18 years and above 60 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It relates developed biscuits with wholesome nutrients and improves immunity, which provides an ampul daily dietary supplement   18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nithya sevaniya biscuits are ideal for nutrient availability , palatability, compactness and convenience  18 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Need for the study:

     A Balanced diet is defined as one which contains a variety of foods in such a quantities and proportions that the needs for energy, amino acids, vitamins, minerals, fats, carbohydrate and other nutrients is adequately met for maintaining health, vitality and general well-being and also makes a small provision for extra nutrients to withstand short duration leanness.  According to ICMR 2020 the energy requirements of an individual are, adult male who does moderate work is 2710Kcal/d, for an adult female who does moderate work is 2130Kcal/d, for children of age group 6-9 is 1700Kcal/d, for pregnant women it is 3070Kcal/ d, for men above or equal to 60 is 1700Kcal/d, for women above or equal to 60 is 1500Kcal/d. Failing to meet these requirements leads to malnourishment and nutritional deficiency disorders. Under nutrition is not only an important cause of childhood morbidity and mortality; but leads also to permanent impairment of physical and mental growth of those who survive. Persistent undernutrition through the growing phase of childhood leads to short stature in adult. About 16.2% of adult men and 18.7% women have body mass index below 18.5 which indicates chronic nutrition deficiency. About 18.5% children are born with low birth weight, 32.1% are underweight for the age group below 5 years of age. A healthy diet helps to protect against malnutrition in all its forms, as well as noncommunicable diseases (NCDs), including diabetes, heart disease, stroke and cancer. The world’s lifestyle has seen a significant transformation in recent years as a result of adjustments made to dietary practices, job schedules, stress levels and sleep cycles. People neglect to invest time and effort in choosing the proper food during this process. As a result, the majority of people neglect to meet their fundamental dietary requirements. This has led to the emergence of numerous diseases that are currently presenting as significant health concerns. Ayurveda has taught us that prevention is better than cure. Prevention of any disease, for that matter, is possible only when there is good health. Ayurveda says that food, sleep and healthy sexual life are the three pillars of life. Food, being the foremost of them, calls for immediate attention. An ancient balanced diet consists of food articles which are explained in Nityasevaniya ahara (The food articles which are advised to take daily that will fulfil the body requirements).Considering that people may not be able to compromise on their daily work to spend adequate time in cooking the right food, the present study aims at creating a dietary supplement using simple natural ingredients prescribed by the Ayurvedic seers. This preparation can be consumed by healthy people of any age group and of either sex. Since time immemorial, these ingredients have proven to play a key role in promotion and maintenance of health.

 Nithya sevaniya ahara dravyas are mentioned in brihatrayee , the dravyas that are mentioned below are from Ashtanga hridhaya sutrasthana matrasitiyam adhyayam

 
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