| CTRI Number |
CTRI/2021/03/032246 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
15/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the correlation between stress and immunity in different constituents persons |
|
Scientific Title of Study
|
An observational study of assessment of stress and imummne response in different prakriti individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Parmar |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital Karol Bagh |
| Address |
PG Department of Kriya Sharir Ayurvedic and Unani Tibbia college and hospital Karol Bagh
Central
DELHI
110005
India |
| Phone |
8209938594 |
| Fax |
|
| Email |
nehaparmar7523@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Rajan |
| Designation |
H.O.D. Department of kriya sharir associate professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital Karol Bagh |
| Address |
PG Department of Kriya Sharir Ayurvedic and Unani Tibbia college and hospital Karol Bagh
Central
DELHI
110005
India |
| Phone |
9818473595 |
| Fax |
|
| Email |
sujataa.rajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Rajan |
| Designation |
H.O.D. Department of kriya sharir associate professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital Karol Bagh |
| Address |
PG Department of Kriya Sharir Ayurvedic and Unani Tibbia college and hospital Karol Bagh
Central
DELHI
110005
India |
| Phone |
9818473595 |
| Fax |
|
| Email |
sujataa.rajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia college and hospital Karol Bagh |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia college and hospital Karol Bagh |
| Address |
Ajmal Khan road Karol Bagh New Delhi 110005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neha Parmar |
Ayurvedic and Unani Tibbia college and hospital Karol Bagh |
PG department of kriya sharir
Central
DELHI |
8209938594
nehaparmar7523@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 |
| Patients |
(1) ICD-10 Condition:Z283||Underimmunization status. Ayurveda Condition: stress patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient should be interested and give their consent for the study work. |
|
| ExclusionCriteria |
| Details |
1. Major disorder like cancer,cardiac disease
2.History of chronic alcohol , tabacco,smoking consumption
3.Pregnent and lactating mother
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate stress and immunity level with the help of biomarkers and find there
correlation |
At the time of enrollment of subjects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the level of stress and immunity in different prakriti individual |
At the time of enrollment of subjects |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/04/2021 |
| 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
|
1.Stress is very common among the people in current era, in this type study show that stress affect on immunity or not with the help of biomarker. 2.this study show that which prakriti are more immunity
METHODOLOGY- STUDY DESIGN-CROSS SECTIONAL OBSERVATIONAL MASKING- OPEN LABLE PURPOSE-RESEARCH AND KNOWING SOME FACTS ABOUT HEALTH STATUS |