| CTRI Number |
CTRI/2026/03/105308 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of menstrual pain on breath holding capacity in adult women |
|
Scientific Title of Study
|
The impact of primary dysmenorrhea on breath holding time in 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 Anwaya Dilip |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college, manipal |
| Address |
Department of physiology, kasturba medical college, manipal, udupi, 576102.
Udupi
KARNATAKA
576102
India |
| Phone |
6238357417 |
| Fax |
|
| Email |
anwaya9876@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnamoorthi Prabhu |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college, manipal |
| Address |
Department of physiology, kasturba medical college, manipal, udupi, 576102.
Udupi
KARNATAKA
576102
India |
| Phone |
8884103507 |
| Fax |
|
| Email |
km.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anwaya Dilip |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college, manipal |
| Address |
Department of physiology, kasturba medical college, manipal, udupi, 576102.
KARNATAKA
576102
India |
| Phone |
6238357417 |
| Fax |
|
| Email |
anwaya9876@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
kasturba medical college manipal karnataka india |
| Address |
department of physiology kasturba medical college manipal,karnataka india pincode- 576102 |
| Type of Sponsor |
Private 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 |
| Dr Anwaya Dilip |
kasturba medical college manipal |
department of physiology kasturba medical college manipal
Udupi
KARNATAKA |
6238357417
anwaya9876@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee-2(student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy females in the age group of 18 to 35 years with pain during menstrual cycle |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
female subjects between ages of 18 to 35 years, who can read and write english, having pain during menstrual cycle, and healthy subjects without pain during menstrual cycles. |
|
| ExclusionCriteria |
| Details |
subjects less than 18 or more than 35 years, having any kind of illness or taking any medication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| breath holding time |
day 2 and day 24 of the menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight, blood pressure, fat percent, lean mass percent, dry lean weight percent, total body water percent, extra cellular water percent, intra cellular water percent, body mass index, body fat mass index, fat free mass index, tidal volume, vital capacity, forced vital capacity, forced expiratory volume in one second, fev1/fvc, pefr, slow vital capacity, maximum voluntary ventilation, mean rr, sdnn, rmssd, pnn50, hf, lf, lf/hf, rhr, tp, vlf |
day 2 and day 24 of the menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/03/2026 |
| 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="0"
Months="0"
Days="22" |
|
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
|
Dysmenorrhea is a common problem affecting young indian females resulting in absenteeism, and restriction in normal daily activities. studies have shown a difference in maximum breath holding time during the menstrual cycle with higher time during mid luteal phase probably due to higher levels of estrogen and progesterone in the mid luteal phase as compared to the early follicular phase, but there is a lack of literature on the breath holding time in subjects with dysmenorrhea. cardiac autonomic function is also different during the menstrual cycle due to effects of estrogen and progesterone and there is a lack of sufficient literature on cardiac autonomic parameters in subjects with dysmenorrhea. studies have shown differences in body composition during different phases of menstrual cycle. this study will help to detect any possible reduced pulmonary functions and cardiac autonomic dysfunction in subjects with dysmenorrhea and help to guide them to appropriate preventive and treatment methods early. |