| CTRI Number |
CTRI/2026/01/101598 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Thyroid Disorders and Their Effect on Menstrual Cycles in Rural Women |
|
Scientific Title of Study
|
Prevalence of Hypothyroidism and Hyperthyroidism and their impact on Menstrual Irregularities among women of reproductive age in Rural area, Tamil nadu |
| 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 Dhayaa Shree S |
| Designation |
Post Graduate |
| Affiliation |
vinayaka missions kirupanandha variyar medical college and hospitals , salem |
| Address |
Department of Community Medicine ,Vinayaka missions kirupanandha variyar medical college and Hospitals , salem
Salem
TAMIL NADU
636308
India |
| Phone |
8610715411 |
| Fax |
|
| Email |
dhayaassree34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Shankar |
| Designation |
Professor |
| Affiliation |
vinayaka missions kirupanandha variyar medical college , salem |
| Address |
Department of Community Medicine , Vinayaka missions kirupanandha variyar medical college and Hospitals, salem
Salem
TAMIL NADU
636308
India |
| Phone |
9655368498 |
| Fax |
|
| Email |
shnkrradhakrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhayaa Shree S |
| Designation |
Post Graduate |
| Affiliation |
vinayaka missions kirupanandha variyar medical college and hospitals , salem |
| Address |
Department of Community Medicine , Vinayaka missions kirupanandha variyar medical college and Hospitals , salem
Salem
TAMIL NADU
636308
India |
| Phone |
8610715411 |
| Fax |
|
| Email |
dhayaassree34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions kirupanandha Variyar medical college and hospitals , salem , Tamil Nadu , India , 642129 |
|
|
Primary Sponsor
|
| Name |
Dr Dhayaa Shree S |
| Address |
Department of Community Medicine , Vinayaka Missions Kirupanandha variyar medical College and Hospitals , Salem , TamilNadu , India , 636308 |
| 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 Dhayaa Shree S |
Field practice area , Poolavari |
field practice area , poolavari , salem ,
Salem
TAMIL NADU |
8610715411
dhayaassree34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HYPOTHYROIDISM AND HYPERTHYROIDISM AMONG REPRODUCTIVE AGE WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
WOMEN WHO GAVE INFORMED CONSENT
WOMEN BETWEEN 18 -49 YEARS |
|
| ExclusionCriteria |
| Details |
WOMEN ON THYROID MEDICATION , LACTATING WOMEN , PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ESTIMATE THE PREVALENCE OF HYPOTHYROIDISM AND HYPERTHYROIDISM AMONG REPRODUCTIVE AGE WOMEN AND THEIR IMPACT ON MENTSRUAL IRREGULARITIES |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
30/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 IS A PROSPECTIVE OBSERVATIONAL STUDY CONDUCTED IN FIELD PRACTICE AREA IN RURAL AREA NAMED POOLAVARI , IN SALEM. TO DETERMINE THE ASSOCIATION BETWEEN THYROID DYSFUNCTION ( HYPOTHYROIDISM AND HYPERTHYROIDISM ) AND MENSTRUAL IRREGULARITIES. AS THERE IS LACK OF AWARENESS AMONG RURAL AREA WOMEN , CONDUCTING THIS STUDY HELPS IN DIAGNOSING THYROID DISORDERS AND HIGHLIGHTS THE EFFECT OF THYROID DISORDERS ON MENSTRUAL CYCLE . |