| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy person |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 |