CTRI Number |
CTRI/2025/04/085849 [Registered on: 28/04/2025] Trial Registered Prospectively |
Last Modified On: |
26/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Integrated Yoga intervention for Primary Dysmenorrhea: A RCT on Biochemical, Hormonal, and Psychosocial Outcomes with Development, Validation, and Feasibility Testing |
Scientific Title of Study
|
Efficacy of an Integrated Yoga Intervention on Biochemical Markers, Hormonal Profiles, Pain, and Psychosocial Well-Being in Women with Primary Dysmenorrhea: Development, Validation, Feasibility Testing |
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 Sanjib K Patra |
Designation |
Professor |
Affiliation |
Central University of Rajasthan |
Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri, Kishnagarh, Ajmer, Rajasthan, India
Ajmer RAJASTHAN 305817 India |
Phone |
8618142265 |
Fax |
|
Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sanjib K Patra |
Designation |
Professor |
Affiliation |
Central University of Rajasthan |
Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri, Kishnagarh, Ajmer, Rajasthan, India
RAJASTHAN 305817 India |
Phone |
8618142265 |
Fax |
|
Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Sanjib K Patra |
Designation |
Professor |
Affiliation |
Central University of Rajasthan |
Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri, Kishnagarh, Ajmer, Rajasthan, India
RAJASTHAN 305817 India |
Phone |
8618142265 |
Fax |
|
Email |
sanjib.patra@curaj.ac.in |
|
Source of Monetary or Material Support
|
Central University of Rajasthan, NH-8, Bandar Sindri, Kishngarh,Ajmer, Rajasthan, India, 305817 |
|
Primary Sponsor
|
Name |
Dr Sanjib Kumar Patra |
Address |
Department of Yoga, Central University of Rajasthan, NH-8 Bandar sindri, Ajmer, Rajasthan, India, 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 Sanjib Kumar Patra |
Swami Kuvalayananda Kaksa, Department of Yoga |
Central University of Rajasthan, NH-8, Bandar Sindri, Kishnagarh, Ajmer, Rajasthan, India Ajmer RAJASTHAN |
08618142265
sanjib.patra@curaj.ac.in |
|
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 |
Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Validated integrated yoga intervention |
Experimental group will receive 60 min structured yoga sessions of validated yoga protocol by certified
yoga therapist, 3 times in a week for 8 weeks followed by yogic counselling session once a week.
Participants will be encouraged for home-based practice of validated yoga protocol 2 times in a week. |
Comparator Agent |
Walking intervention |
Control group participants will get a 45-minute walking intervention minimum 3 days a week for eight weeks. The control group will be called for a weekly meeting to assess their walking activity and
interact. Participants in the control group will be asked to maintain a logbook to monitor their walking frequencies during the study period.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
26.00 Year(s) |
Gender |
Female |
Details |
The study will include women aged 18-26 with regular menstrual cycles (21-35 days) and a clinical diagnosis of primary dysmenorrhea. Participants must experience moderate to severe menstrual pain along with symptoms like headaches, nausea, and vomiting, with pain onset 6-12 hours after menstruation begins and lasting 8-72 hours. They must experience at least 4 consecutive painful periods in the past six months. Participants must be healthy with no major chronic illnesses and no regular yoga practice in the last six months, and they must provide written informed consent. |
|
ExclusionCriteria |
Details |
women with secondary dysmenorrhea or significant gastrointestinal, gynaecological or
autoimmune disease or gynaecological surgery, or, those using hormonal contraceptives or medications
that could affect the menstrual cycle or pain perception. |
|
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 |
Protaglandins
Progestrone
TNF alpha
Interluekin(IL6 and IL 1 beta) and Pain intensity |
At Baseline and after 8 week of intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
1 Pain outcomes including primary dysmenorrhea severity will assess through WaLIDD Scale,and associated symptoms through Cox Menstrual Symptom Scale (CMSS)
2.Autonomic measures such as Short-term HRV via Biopac MP36.
3. Cognitive functions via PEBEL software includes variables such as Selective attention, Sustained attention, Working memory and Executive function.
4. Psychosocial measures includes Menstrual Distress Questionnaire (MEDI-Q), Depression, Anxiety and Stress Scale (DASS-21), Pain Catastrophizing Scale (PCS), Health-Related Productivity Questionnaire (HRPQ), Quality of Life Enjoyment and Satisfaction Questionnaire-short form (Q-LES-Q-SF), Functional and Emotional Measure of Dysmenorrhea (FEMD), Sleep Quality (Pittsburgh Sleep quality index) and World Health Organization Quality of life scale (WHOQOL-BREF)
|
At Baseline and after 8 week of intervention |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/05/2025 |
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="5" 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
|
Primary dysmenorrhea (PD), characterized by severe menstrual
pain in the absence of pelvic pathology, is a pervasive yet neglected public
health issue affecting 50–90% of menstruating individuals, predominantly
adolescents and young women. Beyond its impact on physical health, primary
dysmenorrhea also affects psychosocial well-being, academic performance, and
daily activities. Research has associated it with absenteeism, decreased
productivity, and a higher likelihood of anxiety and depression. Despite its
prevalence, PD remains underprioritized in healthcare systems, often dismissed
as a “normal” part of menstruation. Current first-line treatments, such as
non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives,
focus on symptom suppression but carry risks like gastrointestinal ulcers,
cardiovascular complications, and hormonal side effects. These interventions
reflect a reductionist biomedical model that overlooks the interconnected
biopsychosocial drivers of PD, including chronic stress, inflammation, and
hormonal imbalances. This gap underscores an urgent need for holistic,
sustainable, and culturally resonant solutions that address root causes while
empowering women to reclaim agency over their health. Yoga rooted in philosophy
of harmonizing mind, body, and spirit, yoga integrates physical postures
(asanas), breath regulation (pranayama), and meditation (dhyana) to promote
holistic well-being. Emerging evidence suggests the yoga ‘s potential in
reducing stress, menstrual pain, modulating pain and inflammatory pathways and
balancing hormones (like cortisol and progesterone). Despite this, critical
gaps remain in existing research, as most studies primarily focus on symptom
relief (such as pain reduction), while offering limited insight into the
underlying biochemical and hormonal mechanisms, including prostaglandins,
inflammatory markers and progesterone imbalance, which are key factors in
primary dysmenorrhea. These studies, while useful, either isolate certain
components of yoga or combine them with non-yogic intervention, leaving a
considerable void in assessing yoga’s holistic potential. However, these yoga
protocols for primary dysmenorrhea lack standardization, cultural specificity,
and rigorous validation, limiting their clinical adoption. This project
addresses these gaps by co-designing a culturally grounded, evidence-based integrated
yoga module with traditional practitioners and biomedical experts, ensuring alignments
of traditional wisdom with modern science. By validating yoga’s efficacy
through biochemical and psychosocial metrics, it advances mechanistic
understanding of mind-body interventions. Through feasibility testing and a
subsequent randomized controlled trial (RCT), the project will explore yoga’s
impact on prostaglandins, cytokines, cortisol, and progesterone, elucidating
how it disrupts PD pathophysiology. This translational approach not only
strengthens yoga’s credibility as an evidence-based therapy but also informs
broader applications for inflammatory and stress-related conditions.
Additionally, the intervention empowers women to participate fully in academic
and professional spheres as primary dysmenorrhea disproportionately impacts
young women during critical educational and career-building years. |