| CTRI Number |
CTRI/2024/12/078380 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Factors Associated with Premenstrual Syndrome Among Young Adults Aged 15-23 Years: A Cross-Sectional Study" |
|
Scientific Title of Study
|
To study the factors associated with premenstrual syndrome
of young adults aged 15-23 yrs old– A cross sectional study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RASHI BUDUKH |
| Designation |
Student |
| Affiliation |
Dr. BMN college of home science |
| Address |
Room no. 903 department of clinical Nutrition and Dietetics 338, Rafi Ahmed Kidwai Road,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019 India
Room no. 903 department of clinical Nutrition and Dietetics 338, Rafi Ahmed Kidwai Road,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019 India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8451881421 |
| Fax |
|
| Email |
rashibudukh22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Batthalwar |
| Designation |
Director- Administration |
| Affiliation |
Sir Vithaldas Thackersey college of Home Science |
| Address |
Sir Vithaldas Thackersey college of Home Science ( Empowered Autonomous Status ), SNDT Women’s University, Juhu, Mumbai - 400 049
S.N.D, T Womens University, Juhu Tara Rd, Santacruz, Mumbai, Daulat Nagar, W, Mumbai, Maharashtra 400049
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9820286174 |
| Fax |
|
| Email |
rekha.battalwar@svt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha Batthalwar |
| Designation |
Director- Administration |
| Affiliation |
Sir Vithaldas Thackersey college of Home Science |
| Address |
Sir Vithaldas Thackersey college of Home Science ( Empowered Autonomous Status ), SNDT Women’s University, Juhu, Mumbai - 400 049
S.N.D, T Womens University, Juhu Tara Rd, Santacruz, Mumbai, Daulat Nagar, W, Mumbai, Maharashtra 400049
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9820286174 |
| Fax |
|
| Email |
rekha.battalwar@svt.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr Bhanuben Mahendra Nanavati College of Home Science Matunga, Mumbai, Maharashtra
400019 |
|
|
Primary Sponsor
|
| Name |
Rashi Budukh |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Road,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019 India |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 |
| rashi budukh |
Dr.BMN College of home science |
Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
8451881421
rashibudukh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva mandal educational society institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no disease conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Na |
Na |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
-15-23 years economic status middle class
- Females with Hormonal issues |
|
| ExclusionCriteria |
| Details |
Those who are critically ill
- Pregnant women |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be a negative association of factors with Pre menstrual syndrome |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effects of PMS symptoms on daily activities, productivity, and overall quality of life, potentially correlated with lifestyle habits |
5 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/12/2024 |
| 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="10"
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
|
This study aims to explore the dietary status and factors associated with premenstrual syndrome in young adults aged 15-23 years. it will evaluate anthropometric measurements, sleep patterns, physical activity, PMS symptoms severity, and stress levels. Conducted as a cross-sectional study with purposive sampling, it targets 100 female participants from a middle-class economic background with hormonal issues, excluding those who are critically ill or pregnant. Data collection will include a self-designed questionnaire on demographics, anthropometry, and dietary habits alongside validated tools for sleep, physical activity, stress, and PMS. The study anticipates finding negative associations between lifestyle factors and PMS contributing to a better understanding of PMS determinants in young adults
|