| CTRI Number |
CTRI/2022/04/041757 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
05/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparitive study |
| Study Design |
Other |
|
Public Title of Study
|
Stress coping capacity in diffrent individuals |
|
Scientific Title of Study
|
An observational study of co-relation between Manasa Prakriti and Stress Coping Capacity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavyashree R N |
| Designation |
P G Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground floor
Kriya Sharir Department
Parul Institute of Ayurved
Parul University
Limda Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8496985912 |
| Fax |
|
| Email |
kavyashreern29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil P Nikhate |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground floor
Kriya Sharir Department
Parul Institute of Ayurved
Parul University
Limda Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9521166422 |
| Fax |
|
| Email |
sunil.nikhate26837@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil P Nikhate |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground floor
Kriya Sharir Department
Parul Institute of Ayurved
Parul University
Limda Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9521166422 |
| Fax |
|
| Email |
sunil.nikhate26837@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved
Parul University
Vadodara Gujarat |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Ground floor
Kriya Sharir Department
Parul Institute of Ayurved
Parul University
Limda Vadodara 391760 |
| Type of Sponsor |
Private 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 Kavyashree R N |
Parul Institute Of Ayurved |
105 Ground floor
Kriya Sharir Department
Parul Institute of Ayurved
Parul University
Limda Vadodara 391760
Vadodara
GUJARAT |
8496985912
kavyashreern29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY STUDENT |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Stress Coping assessment | (Procedure Reference: Reference Kenneth B. Matheny, Ph.D., ABPP and Christopher McCarthy, Ph.D. 2000), Procedure details: Critical analysis of fundamental Manasa prakriti will be assessed and then Critical analysis of Stress Coping Capacity will be assessed with Stress Coping Resource Inventory Scale/SCRI scale in the same individuals.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently Healthy Volunteers irrespective of Gender, Caste and Religion
2.Age 18 – 30 years.
3.Student studying (Same work environment) in Parul University(other than PIA)
|
|
| ExclusionCriteria |
| Details |
1.Individuals having Systemic Disorders
2.Individuals with Psychosomatic Disorders
3.Individuals who practice Yoga, Meditation, 4.Pranayama in their daily routine
5.Pregnant and Lactating Women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is co-relation between Manasa Prakriti and Stress Coping Capacity |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
15/04/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mental health issues are increasing in the recent time Mainly, stress has become an inevitable and the most unwanted companion of civilization.The young generation is under tremendous stress due to their education, carrier and jobs. With the help of accurate Manasa Prakriti Assessment we can advice for further management to avoid stress induced diseases.
|