| CTRI Number |
CTRI/2024/01/061790 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Menopause on cognitive function |
|
Scientific Title of Study
|
Prevalence of cognitive Impairment in menopausal 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 |
Dr Divya Shukla |
| Designation |
Pg Student |
| Affiliation |
Amity Institute of Health Allied Sciences, physiotherapy , Amity University |
| Address |
Amity Institute Allied Sciences, physiotherapy department F-1block, ROOM NO .007
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9891858500 |
| Fax |
|
| Email |
Divyashukla998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Pragya Kumar |
| Designation |
Assistant professor |
| Affiliation |
amity university |
| Address |
amity university Sector 125, Noida , Uttar Pradesh 201301
New Delhi
DELHI
201301
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Shukla |
| Designation |
physiotherapist |
| Affiliation |
Amity Institute of Health Allied Sciences, physiotherapy, Amity University |
| Address |
Amity Institute Health Allied Sciences, physiotherapy department F-1 block , Room No 007
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9891858500 |
| Fax |
|
| Email |
Divyashukla998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amity Institute of health Allied Science, physiotherapy department F-1 block Room No 007 |
| Amity Institute of health Allied Sciences, physiotherapy department |
|
|
Primary Sponsor
|
| Name |
Dr Divya Shukla |
| Address |
Amity Institute of Health Allied Science, Physiotherapy, Amity University uttar pradesh |
| Type of Sponsor |
Other [Self Sponsored ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Shukla |
Amity University Uttar Pradesh |
Amity Institute of Health Allied Sciences, Physiotherapy Department F-1block Room No. 007
Gautam Buddha Nagar
UTTAR PRADESH |
9891858500
Divyashukla998@gmail.com |
| DIVYA SHUKLA |
South delhi |
South delhi(Community)
South
DELHI |
9891858500
divyashukla998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Science, Amity University Uttar Pradesh |
Approved |
| Amity Institute of Health Allied Sciences |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menopausal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
aged 40 to 60 years
female |
|
| ExclusionCriteria |
| Details |
pre-existing neurological conditions( e.g. Alzheimer disease, Parkinson disease)
severe mental health conditions ( e.g., schizophrenia , severe depressions)
history of cognitive impairment or dementia diagnosis.
history of substance abuse or alcoholism.
use of medication that could significantly impact cognitive impairment function (e.g., sedative ,antipsychotics0 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence and severity of cognitive impairment among menopausal women |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO determine the association between cognitive changes among different menopausal phase |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/02/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 25-01-2024 and end date provided 15-03-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The purpose of this study is to examine the prevalence of cognitive impairment in women and the potential link between menopause and changes in cognitive performance. Methodology: A cross-sectional study design using purposive sampling. the study will recruit 80 menopausal women aged 40 to 60 from Delhi (south Delhi) of India. Study participants were selected from among healthy volunteers, and eligible individuals recommended by volunteers from religious gatherings, women’s gyms, and parks. the informed consent form was taken from participants and completed the given questionnaire on the menopause rating scale prior to testing in order to measure menopause symptoms and divide people into three menopausal phases. Following the MRS, the subject underwent the Montreal Cognitive Assessment (MoCA), the data will be analyzed which assessed their level of cognitive function. |