| CTRI Number |
CTRI/2025/04/085497 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on impact of yoga on symptoms, biomarkers, heart rate variability and cognition among female students with premenstrual syndrome |
|
Scientific Title of Study
|
Efficacy of Integrated Yoga on the symptoms of premenstrual syndrome, biomarkers, heart rate variability, quality of life and cognitive functions among female university students with premenstrual syndrome: a randomised controlled trial |
| 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 Kashinath G Metri |
| Designation |
Assistant Professor |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri
Ajmer
RAJASTHAN
305817
India |
| Phone |
9035257626 |
| Fax |
|
| Email |
kashinath@curaj.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Darshana Hazarika |
| Designation |
Research Scholar |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri
Ajmer
RAJASTHAN
305817
India |
| Phone |
6001785253 |
| Fax |
|
| Email |
2023phdyg002@curaj.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashinath G Metri |
| Designation |
Assistant Professor |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri
Ajmer
RAJASTHAN
305817
India |
| Phone |
9035257626 |
| Fax |
|
| Email |
kashinath@curaj.ac.in |
|
|
Source of Monetary or Material Support
|
| Central University of Rajasthan, NH-8, Bandar Sindri, Ajmer, Rajasthan, India, 305817 |
|
|
Primary Sponsor
|
| Name |
Dr Kashinath G Metri |
| Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri, Ajmer, Rajasthan, 305817 |
| 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 Kashinath G Metri |
Central University of Rajasthan |
Faculty room no. 1 ( Sri Aurobindo kaksa), Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri, Ajmer, Rajasthan-305817
Ajmer
RAJASTHAN |
9035257626
kashinath@curaj.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Institutional Ethics Committee, Central University of Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Usual routine |
Routine as usual without additional interventions |
| Intervention |
Yoga therapy |
A 60-minute validated yoga module comprising sukshma vyamas(loosening practies), asana (postures),pranayamas (voluntary regulated breathing), mudras (hand-gestures), relaxation and meditation for 3 times a week for 8 consecutive weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1) Consenting female university students with PMS residing in the university hostels
2) Females within the age range 18-30 years
3) Must stay in university campus hostels
|
|
| ExclusionCriteria |
| Details |
1) Females diagnosed with other gynecological disorders, physical or mental disorders, and menstrual irregularities
2) Females undergoing any long term medications
3) Females who are overweight or obese
4) Females with history of addiction or substance abuse
5) Females who has been exposed to yoga practices in the past 6 months
6) Females recieving any other mind-body therapies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Biomarkers: Progesterone and Serotonin
2) Cognitive functions: sustained attention, working memory, and executive function (inhibitory control)
3) Symptoms of Premenstrual syndrome, Profiles of mood states, Premenstrual syndrome related quality of life |
Baseline (0 week), post (after 8 weeks), and follow-up (after 12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Cardiac autonomic function: Heart rate variability
2) Sleep quality
3) Menstrual pain. |
Baseline (0 week), post (after 8 weeks), and follow-up (after 12 weeks) |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/05/2025 |
| 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="4"
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
|
Premenstrual syndrome (PMS) is a complex disorder characterized by periodic and recurring physical, psychological, emotional, and behavioral symptoms experienced by some females during their reproductive age. PMS significantly impairs quality of life, affecting personal relationships, academic performance, and professional efficiency, thereby highlighting its multifaceted burden on patients’ overall well-being. Evidence shows that yoga has numerous health benefits on female reproductive health, by facilitating hormonal regulation, improving blood circulation. Yoga increases vagal tone and thereby reducing stress, enhancing mood, cognitive function and emotional-mental health. Previous studies on the effects of yoga in managing premenstrual syndrome (PMS) have primarily focused on subjective assessments, such as symptom severity, quality of life, and related variables like pain. However, no research to date has incorporated objective measures, such as biomarkers, and heart rate variability which could enhance the robustness and reliability of the findings. In this study, we propose to evaluate the impact of a newly developed and validated yoga module specifically tailored to the four phases of the menstrual cycle (Menstrual, follicular, ovulation, and luteal phase). This module is designed to align with the natural hormonal dynamics and includes practices such as loosening exercises, yoga postures, bandhas, mudras, breathing techniques, relaxation, and meditation and assess its impact on progesterone and serotonin, heart rate variability, cognitive functions, symptoms of PMS, PMS related quality of life, mood states, pain, and quality of sleep. The intervention will be assessed among female university students experiencing PMS (as screened by "Premenstrual Syndrome Screening Tool") within the age range 18-30 years old. The experimental group will follow a 60 minutes module for 3 sessions per week 2 months. While, the control group will follow their usual routine. If successful, the study could position yoga as a low-cost, community-based intervention for managing premenstrual syndrome and its associated challenges, contributing to the growing field of mind-body research |