| CTRI Number |
CTRI/2023/05/052898 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
15/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect on agnibala (digestive power) in various deha prakriti (body Constitution) during examination period |
|
Scientific Title of Study
|
To Study The Effect on Agnibala In Various Deha Prakriti During Examination Period |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajeet |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra |
| Address |
Room number 26,P.G. Department of Kriya Sharir,Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7048991196 |
| Fax |
|
| Email |
drajeet96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra khurana |
| Designation |
Principal |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra |
| Address |
Room number 25,P.G. Department of Kriya Sharir,Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416337325 |
| Fax |
|
| Email |
dr.devendrakhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra |
| Address |
Room number 26,P.G. Department of Kriya Sharir,Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7048991196 |
| Fax |
|
| Email |
drajeet96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic College and hospital |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Government Ayurvedic College,Kurukshetra |
| Address |
Shri Krishna Government Ayurvedic College and hospital, umari road sector-8, Kurukshetra |
| Type of Sponsor |
Government medical college |
|
|
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 Ajeet PG scholar |
Shri Krishna Government Ayurvedic College and Hospital |
Room Number 61A,Department Of Kriya Sharir,Shri Krishna Government Ayurvedic College and Hospital, Umari road sector 8,Kurukshetra,Haryana,
Kurukshetra
HARYANA |
7048991196
drajeet96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prakriti base |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Apparently Healthy young male & female individuals.
Age between 17 to 34 years. |
|
| ExclusionCriteria |
| Details |
Individuals less than 17 years and above 34 years.
Taking any long term medicine presently.
The individuals have any underline chronic diseases.
Pregnancy and lactation History of Cardiovascular disorder.
History of any Respiratory disorders and digestive related disease .
History of Diabetes mellitus, Hypertension, Thyroid .
History of Major surgery in the recent past.
History of Alcohol & Smoking. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand and analyse the effect of agnibala in various deha prakriti during examination period. |
Prakriti and agnibala performa will be filled- before three month and 15 min before examination period agnibala performa will filled by subject. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collect literature regarding various deha Prakriti.
To collect literature regarding Agnibala.
To determine the effect of agnibala during examination period in various deha prakriti |
Prakriti and agnibala performa will be filled by healthy volunteer before three month and 15 min of examination |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Agnibala is the main concept on which person health state depends.
In normal state it maintains health of individual and in abnormal state it causes disease.
The prevalence rate of agni (digestive system) related disease is 49% female and 36.6% male in adult in worldwide.
Every individual is different from another and hence should be considered as different prakriti.
By assessing the prakriti of an individual effect on agnibala during examination period. Various works have done determining prakriti, agnibala independently. But till yet there is perhaps no work has been done to establish the effect on agnibala in various deha prakriti during examination period.
So, there was need to make an effort to find out this relationship. By assessing prakriti by using validated performa and agnibala by using validating agni analysis performa. |