| CTRI Number |
CTRI/2025/09/095415 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| 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
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krithika K |
The Oxford Medical College Hospital and Research Centre |
Department of Obstetrics and Gynecology, Yadavanahalli, Attibele, Behind La Classic Hotel, Bengaluru-Chennai Hwy, Rajajinagar 3rd Block, Anekal, Bangalore, Karnataka-562107, India
Bangalore
KARNATAKA |
08061854138
principal.tomch@theoxford.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeSVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No intervention given, allowed to do regular activities. |
| Intervention |
Yoga |
Validated Yoga Module: Yoga Asanas, Pranayama Practices, and Deep Relaxation Techniques/ Meditation.
Duration: 3 months. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged 18 to 30 years
2. Females with a visual analogue score of 4 or higher
3. Females who consented to participate in the study and are willing to be randomised
4. They should be university or college female students
5. No prior regular yoga practice |
|
| ExclusionCriteria |
| Details |
1. History of pelvic or abdominal surgery
2. Receiving any alternative treatments
3. Reported history of mental illness or substance abuse based on self report
4. Females with pathological pelvic conditions and any chronic illness
5. Married women and those who intend 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
Modification(s)
|
| Outcome |
TimePoints |
COX Menstrual Symptom Scale
CMSS |
Baseline and Post- 12 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Prostaglandin PGE2 biomarker
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-12 Weeks |
|
Target Sample Size
Modification(s)
|
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)
|
20/08/2026 |
| 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
Modification(s)
|
Years="1"
Months="0"
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
Modification(s)
|
This randomised waitlist-controlled trial investigates the impact of a validated yoga practice 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 PGE2 biomarker, 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 three-month yoga programme. The waitlisted control group will continue with their usual lifestyle and will be offered yoga practices after the intervention is completed. The study hypothesises that 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. |