| CTRI Number |
CTRI/2025/12/098433 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding QTc Changes in Women Before and After Menopause with Balghami Mizaj |
|
Scientific Title of Study
|
A Cross-Sectional Study to Assess QTc Interval in Females of Reproductive age Verses Postmenopausal Females of BALGHAMI 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 |
Anza Ali |
| Designation |
PG SCHOLAR |
| Affiliation |
STATE UNANI MEDICAL COLLEGE |
| Address |
State Unani Medical College Himmat Ganj Prayagraj UP
Department of MUNAFEUL Aza State Unani Medical College Himmat Ganj Prayagraj UP
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7503313795 |
| Fax |
|
| Email |
anza.ali06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Nasiruddin |
| Designation |
Reader / H.o.D. |
| Affiliation |
STATE UNANI MEDICAL COLLEGE |
| Address |
Department of MUNAFEUL AZA State Unani Medical College and Hospital Himmat Ganj Prayagraj UP211001
Department of MUNAFEUL AZA State Unani Medical College and hospital Himmat Ganj Prayagraj UP211001
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9927353773 |
| Fax |
|
| Email |
jdnasir81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anza Ali |
| Designation |
PG SCHOLAR |
| Affiliation |
STATE UNANI MEDICAL COLLEGE |
| Address |
Department of MUNAFEUL Aza State Unani Medical College Himmat Ganj Prayagraj UP
State Unani Medical College Himmat Ganj Prayagraj UP 211001
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7503313795 |
| Fax |
|
| Email |
anza.ali06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
STATE UNANI MEDICAL COLLEGE AND HAHRDM HOSPITAL |
| Address |
Department of MUNAFEUL Aza State Unani Medical College Himmat Ganj Prayagraj UP211001 |
| 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 |
| Anza Ali |
state unani medical college and HAHRDM HOSPITAL |
Department of MUNAFEUL Aza State Unani Medical College Himmat Ganj Prayagraj UP
Allahabad
UTTAR PRADESH |
07503313795
anza.ali06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| communication of decision of the institutional ethics committee for biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy females of different age group |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
BALGHAMI Mizaj Females
Group A Reproductive Age Females
Group B Postmenopausal Females |
|
| ExclusionCriteria |
| Details |
DAMWI SAFRAWI SAUDAWI Mizaj
Known Case of Any Acute or Chronic Illness Affecting QT INTERVAL
Pregnant Women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare QTc Interval Values Between Reproductive Age And Postmenopausal Females of BALGHAMI Mizaj |
To compare QTc Interval Values Between Reproductive Age 18 And Postmenopausal Females 65 of BALGHAMI Mizaj for 1 year and 6 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
15/12/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A cross sectional study is planned to compare the QTc interval between females of reproductive age and postmenopausal females who have a Balghami mizaj. QTc reflects the electrical activity of the heart and is influenced by hormonal changes. Reproductive age women have cyclic hormonal effects, while postmenopausal women have reduced estrogen, which may lengthen QTc. Balghami mizaj is traditionally linked with slower and colder body functions, but its relation with QTc is not well studied. This study records QTc using standard ECG and assesses mizaj through the approved questionnaire to understand differences between the two groups and to connect Unani temperament concepts with modern cardiac evaluation. |