| CTRI Number |
CTRI/2023/09/057861 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Mood and Cognition during the Menstrual Cycle |
|
Scientific Title of Study
|
To Study the Dynamics of Mood and Cognition During Different Phases of the Menstrual Cycle- An Observational Study Conducted on Young Adults |
| 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 Payal Bhalla |
| Designation |
Associate professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 221
Department of Physiology
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
9810402261 |
| Fax |
|
| Email |
pb_payal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payal Bhalla |
| Designation |
Associate professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 221
Department of Physiology
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
9810402261 |
| Fax |
|
| Email |
pb_payal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Bhalla |
| Designation |
Associate professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.221
Department of Physiology
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
9810402261 |
| Fax |
|
| Email |
pb_payal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college, New
Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Payal Bhalla |
| Address |
Department of Physiology
Maulana Azad Medical College |
| Type of Sponsor |
Other [Self] |
|
|
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 Payal Bhalla |
Maulana Azad Medical College, New Delhi |
Room number 221
Department of Physiology
Central
DELHI |
9810402261
pb_payal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young healthy females with regular menstrual cycle ( 18-25 years of age) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Regular Menstrual Cycles
Unmarried |
|
| ExclusionCriteria |
| Details |
Diagnosed with-
Mood disorders or Cognitive function disorders
Eating disorders
Polycystic Ovarian Disease,
Irritable Bowel Syndrome,
Dysmenorrhea ,Irregular menstrual cycle, Oligomenorrhoea / Amenorrhea,
Pre Menstrual Dysphoric Disorder
Recent injury/ trauma / surgery/ hospitalisation (in the past 2 months),
Any Hormonal/ endocrine dysregulations or Exogenous hormonal therapy
Obese individuals,
Hypertension or other chronic diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation of mood and cognition with phases of the menstrual cycle in healthy young women experiencing normal menstrual cycles
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate cognitive abilities with the mood of the participant studying how mood can affect cognition.
To study the broader picture of dominant mood pattern during the menstrual, follicular & luteal phases of the menstru |
12 th & 26th days of 2 menstrual cycles |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2023 |
| 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)
|
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
|
Study would be conducted on young females from Delhi.We intend to monitor 2 menstrual cycles and conduct specific cognitive function tests for verbal working memory and attention span during the Follicular phase (12th day) during which estrogen levels are high and Luteal phase (26th day)during which estrogen levels are low(13).
The cognitive function tests will be performed 4 times (2 times per month) to help avoid daily stressors that may affect cognitive abilities.
The participants will also be assessed using the Brief Mood Inspection Scale (14)to assess mood before performing the tests to help establish a confluent correlation between cognition with mood.
To assess the general mood on a daily basis for 2 months , all participants would be asked maintain a ‘Mood Diary’ to describe their day .They would maintain this diary for 2 months and fill the dominant mood pattern on a daily basis.
|