| CTRI Number |
CTRI/2025/06/089891 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship Between Temperament (Mizaj) and Errors of Refraction and Presbyopia |
|
Scientific Title of Study
|
A Cross-sectional, Observational Study to Correlate Different Types of Mizaj (Temperament) in Patients Diagnosed with Errors of Refraction and Presbyopia. |
| 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 Adnan Mastan |
| Designation |
Assistant Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
OPD Room Number 8 Department of Ain Uzn Anf Halaq wa Asnan Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh
Central
DELHI
110005
India |
| Phone |
9213495296 |
| Fax |
|
| Email |
dradnanautc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adnan Mastan |
| Designation |
Assistant Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
OPD Room Number 8 Department of Ain Uzn Anf Halaq wa Asnan Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh
Central
DELHI
110005
India |
| Phone |
9213495296 |
| Fax |
|
| Email |
dradnanautc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adnan Mastan |
| Designation |
Assistant Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
OPD Room Number 8 Department of Ain Uzn Anf Halaq wa Asnan Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh
Central
DELHI
110005
India |
| Phone |
9213495296 |
| Fax |
|
| Email |
dradnanautc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi 110005 INDIA |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ajmal Khan Road Karol Bagh New Delhi 110005 INDIA |
| 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 Adnan Mastan |
Ayurvedic and Unani Tibbia College and Hospital |
OPD Room Number 8 Department of Ain Uzn Anf Halaq wa Asnan Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi 110005 INDIA
Central
DELHI |
9213495296
dradnanautc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H522||Astigmatism, (2) ICD-10 Condition: H520||Hypermetropia, (3) ICD-10 Condition: H521||Myopia, (4) ICD-10 Condition: H524||Presbyopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with refractive errors (myopia, hypermetropia, astigmatism) and/or presbyopia.
Patients willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with a history of ocular surgery or trauma.
Patients with other ocular diseases (e.g., glaucoma, cataract) that may affect vision independently of refractive errors.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between Mizaj type and specific refractive error |
At the time of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distribution of Mizaj types among patients with refractive errors and presbyopia |
Data Analysis Phase |
| Association between Mizaj and severity of refractive error |
At enrollment |
| Demographic pattern analysis |
At enrollment (via structured interview/questionnaire) |
|
|
Target Sample Size
|
Total Sample Size="390"
Sample Size from India="390"
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)
|
07/07/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Background and Rationale In Unani medicine the concept of mizaj (temperament) is fundamental to understanding the health and disease state of an individual. Each person’s mizaj is believed to influence their susceptibility to various diseases. Refractive errors such as myopia, hypermetropia, astigmatism, and presbyopia are common ophthalmic conditions that affect a significant portion of the population. However, there is limited research exploring the relationship between different types of mizaj and these refractive errors. This study aims to investigate this potential correlation, which may provide insights for more personalized treatment approaches in Unani medicine.
Objectives To identify the predominant mizaj types among patients diagnosed with various refractive errors (myopia, hypermetropia, astigmatism) and presbyopia. To analyze the correlation between different types of mizaj and the occurrence of specific refractive errors. To explore the potential implications of mizaj in the management and treatment of these conditions from a Unani medicine perspective. |