| CTRI Number |
CTRI/2025/09/095415 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on pain, mental health, and body changes during menstrual cramps |
|
Scientific Title of Study
|
Effect of Yoga on Pain, Psychological Symptoms and Prostaglandin Levels in Primary Dysmenorrhea: A Randomized 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 |
Reena Singh |
| Designation |
Senior Research Fellow |
| Affiliation |
S-VYASA Deemed to be University |
| Address |
Prashanti Kuteeram, S-VYASA Deemed to be University, Division of Yoga and Physical Sciences,
Jigani, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9005160723 |
| Fax |
|
| Email |
reena.vns0511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Majumdar |
| Designation |
Professor and HOD |
| Affiliation |
S-VYASA Deemed to be University |
| Address |
Prashanti Kuteeram, S-VYASA Deemed to be University, Division of Yoga and Lifescience, Molecular Bioscience and Geroscience,
Anvesana Research Lab, Jigani, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9036800821 |
| Fax |
|
| Email |
majumdar.vijaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reena Singh |
| Designation |
Senior Research Fellow |
| Affiliation |
S-VYASA Deemed to be University |
| Address |
Prashanti Kuteeram, S-VYASA Deemed to be University, Division of Yoga and Physical Sciences,
Jigani, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9005160723 |
| Fax |
|
| Email |
reena.vns0511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support provided by S-VYASA, deemed to be University, Jigani,
Bengaluru, 560105 , India |
|
|
Primary Sponsor
|
| Name |
Reena Singh |
| Address |
Prashanti Kutiram, S-VYASA University, Jigani, Bangalore,
Karnataka-560105 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Prof Dr Indirani K S |
Bishop Cotton Womens Christian College |
Department of Law, 19, 3rd Cross , Mission Road, C S I Compound, Bengaluru, Karnataka 560027
Bangalore
KARNATAKA |
8022121898
bcwclc2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No intervention given, allowed to do regular activities. |
| Intervention |
Yoga |
Validated Yoga Module-Yoga Asanas Pranayama practices Deep Relaxation Techniques.
Duration-6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged 18 to 28 years.
2. Females complaining of painful menstruation at least two consecutive cycles.
3. Females with Visual Analogue Score (VAS) 5 or higher.
4. Females having a regular menstrual cycle (28± 7 days); regular menses for at least six previous cycles.
5. Females who consented to participate in the study and are willing to be randomized.
6. They should be university/college students and commit to an initial 3 months of regular practice of yoga.
7. No prior regular yoga practice (less than once a week in the past 6 months).
|
|
| ExclusionCriteria |
| Details |
1. Females with irregular menstrual cycle.
2. History of pelvic or abdominal surgery.
3. Receiving any alternative treatments.
4. Reported history of mental illnesses or substance abuse (based on their self-report).
5. Females of pathological pelvic conditions and Polycystic Ovarian Disease (PCOD) through their medical history.
6. Married women and those who intent to get married within the proposed intervention duration.
|
|
|
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 |
COX menstrual symptom scale
(CMSS) |
Baseline and Post(24 Weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Prostaglandin PGE2 by ELISA
2.Pain severity assessment by VAS
3.Emotion Regulation Questionnaire ERQ
4.Menstrual sensitivity index MSI
5.Perceived Stress Scale PSS
6.Dysmenorrhea Symptom Interference scale
DSI
7.Dysmenorrhea Daily Diary |
Baseline & Post (24 Weeks) |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
10/10/2025 |
| 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="1"
Months="6"
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 randomized waitlist-controlled trial investigates the impact of a validated yoga practices on menstrual pain, psychological outcomes, and prostaglandin E2 levels in female college students with primary dysmenorrhea. The study evaluates multiple outcomes, including menstrual pain (Visual Analogue Scale), menstrual symptom severity (Cox Menstrual Symptom Scale), prostaglandin levels (measured by ELISA), Stress (Perceived Stress Scale), emotion regulation (Emotion Regulation Questionnaire), menstrual sensitivity (Menstrual Sensitivity Index), symptom interference, and daily symptom patterns. Participants in the intervention group will undergo a validated six-month yoga program delivered in a hybrid format. The waitlisted control group will continue with their usual lifestyle and will be offered yoga practices after intervention completion. The study hypothesizes that the yoga will significantly reduce menstrual pain, improve stress management and emotional regulation, and lower prostaglandin levels, thereby enhancing menstrual and psychological health in females with primary dysmenorrhea. |