| CTRI Number |
CTRI/2021/12/038947 [Registered on: 27/12/2021] Trial Registered Prospectively |
| Last Modified On: |
24/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
PRIMARY DYSMENORRHOEA AND PREMENSTRUAL SYMPTOMS IN COLLEGE STUDENTS |
|
Scientific Title of Study
|
PREVALENCE OF PRIMARY DYSMENORRHEA AND PREMENSTRUAL SYMPTOMS IN COLLEGE STUDENTS AND ITS IMPACT ON ACADEMIC PERFORMANCE AND THEIR WILLINGNESS TO SEEK HELP |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naseema A |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no 62 New nurses hostel Department of obstetrics and gynaecology
Maulana Azad Medical College
Room No 62 New nurses hostel
Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
6383145406 |
| Fax |
|
| Email |
naseema.zee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latika Sahu |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no 15
Gynae ward 1A
Dept of obst and gynae
Maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9654962666 |
| Fax |
|
| Email |
latikasahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Latika Sahu |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no 15
Gynae ward 1A
Department of obst and gynae
Maulana azad medical college
North East
DELHI
110002
India |
| Phone |
9654962666 |
| Fax |
|
| Email |
latikasahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL |
| Address |
maulana azad medical college |
| 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 |
| Naseema |
Maulana azad medical college |
Room no 15
Gynae ward 1A
Dept of obst and gynae
Maulana azad medical college
New Delhi
DELHI |
6383145406
naseema.zee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary dysmenorrhea |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Female |
| Details |
Medical students |
|
| ExclusionCriteria |
| Details |
History of abortion or pegnancy
Chronic ds such as diabetes
Already diagnosed psychiatric condition
Already diagnosed case of secondary dysmenorrhoea and is on treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the prevalence of primary dysmenorrhoea and premenstrual symptoms among medical students |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Impact of primary dysmenorrhoea and premenstrual symptoms on academic performance of students
willingness to seek help if not reason |
1 year |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
01/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is to study the prevalence of primary dysmenorrhoea and premenstrual symptoms among medical students and their willingsness to seek help and if not reason for the same.This study enables us to know about the one of the important health problems of adolescents and to address about it.It is to study about the psychological and physical factors involved in primary dysmenorrhea |