| CTRI Number |
CTRI/2025/09/094806 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find relation between cognitive function and hypertension in elderly men and women |
|
Scientific Title of Study
|
Cognitive Function Assessment in Elderly Hypertensive Men and Women |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawana Swami |
| Designation |
Second MBBS student |
| Affiliation |
RUHS College of Medical Sciences Jaipur |
| Address |
RUHS college of medical sciences, sector 11, kumbha marg, pratap nagar,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302033
India |
| Phone |
7073645289 |
| Fax |
|
| Email |
Swamibhawana27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sonali sharma |
| Designation |
Professor |
| Affiliation |
RUHS College of Medical Sciences Jaipur |
| Address |
2nd floor, Biochemistry department,RUHS college of medical sciences, sector 11, kumbha marg, pratap nagar,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
Sonalisharma14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawana Swami |
| Designation |
Second MBBS student |
| Affiliation |
RUHS College of Medical Sciences Jaipur |
| Address |
RUHS college of medical sciences, sector 11, kumbha marg, pratap nagar,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302033
India |
| Phone |
7073645289 |
| Fax |
|
| Email |
Swamibhawana27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support (only): RUHS and associated hospitals, sector11, kumbha marg, pratap nagar, jaipur 302033 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Sonali Sharma |
RUHS college of medical sciences, Jaipur |
General medicine department of RUHS and associated hospitals , Sector 11, kumbha Marg, Pratap Nagar , Jaipur Rajasthan
Jaipur
RAJASTHAN |
9414314678
sonalisharma14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of RUHS college of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of age 60 years and above.
2. Diagnosed with hypertension( Blood pressure 140/90mmHg) or currently on antihypertensive medication.
3.Participants must have primary education ,they should be able to read and write in Hindi and english language.
4.Participants those who give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.History of stroke, dementia and other neurological disorders affecting cognitive function.
2.Current use of medication known to significantly affecting cognitive function(Certain antipsychotic and anticholinergic).
3.Acute illness and hospitalisation in the past month.
4.Severe visual and hearing impairment that may interfere with cognitive assessment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Gender-specific cognitive decline patterns in hypertensive elderly individuals
using MoCA tool.
Determination of the prevalence of cognitive impairment among elderly hypertensive Individuals.
|
2months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate influence of duration & severity of hypertension on cognitive outcomes
2 To identify & compare specific cognitive domain that may be differentially affected in hypertensive men versus women
3 To analyse the relation between duration of hypertension & cognition in both male & female participants |
2 month |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
10/10/2025 |
| 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="2"
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
|
Hypertension, a highly prevalent disease .it correlated with increased risk of developing cardiac and cerebrovascular complications.These complications often associated with severe cognitive impairment.Hypertension is associated with changes in the vascular structure and function,leading to cognitive decline. The study shall provide insights into the cognitive function of elderly hypertensives.Potential gender specific pattern in cognitive decline will be identified. The study will provide prevalence of cognitive impairment in elderly hypertensive population and contribute to understanding of potentially informing prevalence of cognitive impairment. |