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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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