| CTRI Number |
CTRI/2026/03/107135 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
ANALYTICAL |
| Study Design |
Other |
|
Public Title of Study
|
Association of stress and and serum cortisol among healthy individuals of different mizaj(temperaments) |
|
Scientific Title of Study
|
An Observational Analytical Study of Serum Cortisol Level and Impact of Stress Level in Healthy Individuals with Reference to Different Mizaj |
| 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 Ansari Farheena Firdaus Mohammed Mustafa |
| Designation |
Md Scholar Unani |
| Affiliation |
Ayurvedic And Unani Tibbia College |
| Address |
Department Of Manafeul Aza ,Ayurvedic And Unani Tibbia College And Hospital,Karol Bagh,New Delhi,India
Central
DELHI
110005
India |
| Phone |
9860800389 |
| Fax |
|
| Email |
farheenaansari1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nazmeen |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic And Unani Tibbia College |
| Address |
Department Of Manafeul Aza ,Ayurvedic And Unani Tibbia College And Hospital,Karol Bagh,New Delhi,India
Central
DELHI
110005
India |
| Phone |
9220037134 |
| Fax |
|
| Email |
nazmeendr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ansari Farheena Firdaus Mohammed Mustafa |
| Designation |
Md Scholar Unani |
| Affiliation |
Ayurvedic And Unani Tibbia College |
| Address |
Department Of Manafeul Aza ,Ayurvedic And Unani Tibbia College And Hospital,Karol Bagh,New Delhi,India
Central
DELHI
110005
India |
| Phone |
9860800389 |
| Fax |
|
| Email |
farheenaansari1999@gmail.vom |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karolbagh,New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic And Unani Tibbia College |
| Address |
Department Of Manafeul Aza ,Ayurvedic And Unani Tibbia College And Hospital Karol Bagh ,New Delhi-110005 |
| 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 Ansari Farheena Firdaus Mohammed Mustafa |
Ayurvedic And Unani Tibbia College And Hospital |
Department Of Manafeul Aza ,Ayurvedic And Unani Tibbia College And Hospital,Karol Bagh,New Delhi,India
Central
DELHI |
09860800389
farheenaansari1999@gmail.vom |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Individual who appears well and is not taking any type of medication
2 Person of both gender
3 Person with age from 19 years
4 Person with age up to 30 years
|
|
| ExclusionCriteria |
| Details |
1 Person with past history of any chronic disease, life style diseases, systemic diseases, endocrine diseases, autoimmune diseases and Trauma.
2 Person with age below 19 years
3 Person age with above 30 years
4 Person taking high dose of certain steroid medicine to treat condition such as asthma, rheumatoid arthritis etc.
5 Person suffering from stress and stress related issue
6 Any type of brain tumors, traumatic brain injury
7 Mental illness
8 Pregnancy
9 Smoking
10 Alcohol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To assess and compare serum cortisol levels among healthy individuals with different mizaj at baseline. |
Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the association between perceived stress levels & serum cortisol levels in healthy individuals at baseline.
2 To compare perceived stress scores among different mizaj types at baseline.
3 To identify mizaj types showing greater stress reactivity based on cortisol levels & stress scores. |
Only at baseline(single time point) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/04/2026 |
| 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 Applicable |
| 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
|
This study is an observational analytical study conducted to evaluate the relationship between serum cortisol levels and perceived stress levels in healthy individuals with reference to different mizaj (temperament) as described in Unani medicine. Cortisol is a stress-related hormone secreted by the adrenal cortex and plays an important role in the physiological response to stress. In this study, serum cortisol levels will be measured through blood samples, while the impact of stress will be evaluated using the Perceived Stress Scale (PSS) score. The mizaj of each participant will be determined using the CCRUM Mizaj Assessment Proforma. After classification of individuals according to their mizaj, the study will analyze and compare serum cortisol levels and PSS scores among different mizaj types to determine which mizaj group shows higher cortisol levels and higher perceived stress scores, indicating increased stress levels. According to the Unani concept, the dominance of a particular khilt (humour) influences the mizaj (temperament) of an individual. Based on the predominance of the four akhlat (Dam, Balgham, Safra, and Sauda), individuals are classified into different mizaj types. In Unani medicine, physiological regulators such as hormones are considered to be related to akhlat-e-muharrika, which influence body functions and temperament. The findings of this study may help to identify mizaj types that are more prone to higher stress levels, which could support early preventive care and lifestyle modifications according to Unani principles for better maintenance of health. |