Integrated Yoga intervention for Primary Dysmenorrhea: A RCT on Biochemical, Hormonal, and Psychosocial Outcomes with Development, Validation, and Feasibility Testing

Not yet recruiting

• Conditions: Primary dysmenorrhea,

• Registration Number: CTRI/2025/04/085849
• Lead Sponsor: Dr Sanjib Kumar Patra

Brief Summary

Primary dysmenorrhea (PD), characterized by severe menstrualpain in the absence of pelvic pathology, is a pervasive yet neglected publichealth issue affecting 50–90% of menstruating individuals, predominantlyadolescents and young women. Beyond its impact on physical health, primarydysmenorrhea also affects psychosocial well-being, academic performance, anddaily activities. Research has associated it with absenteeism, decreasedproductivity, and a higher likelihood of anxiety and depression. Despite itsprevalence, PD remains underprioritized in healthcare systems, often dismissedas a “normal” part of menstruation. Current first-line treatments, such asnon-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 interventionsreflect a reductionist biomedical model that overlooks the interconnectedbiopsychosocial drivers of PD, including chronic stress, inflammation, andhormonal imbalances. This gap underscores an urgent need for holistic,sustainable, and culturally resonant solutions that address root causes whileempowering women to reclaim agency over their health. Yoga rooted in philosophyof harmonizing mind, body, and spirit, yoga integrates physical postures(asanas), breath regulation (pranayama), and meditation (dhyana) to promoteholistic well-being. Emerging evidence suggests the yoga ‘s potential inreducing stress, menstrual pain, modulating pain and inflammatory pathways andbalancing hormones (like cortisol and progesterone). Despite this, criticalgaps remain in existing research, as most studies primarily focus on symptomrelief (such as pain reduction), while offering limited insight into theunderlying biochemical and hormonal mechanisms, including prostaglandins,inflammatory markers and progesterone imbalance, which are key factors inprimary dysmenorrhea. These studies, while useful, either isolate certaincomponents of yoga or combine them with non-yogic intervention, leaving aconsiderable void in assessing yoga’s holistic potential. However, these yogaprotocols for primary dysmenorrhea lack standardization, cultural specificity,and rigorous validation, limiting their clinical adoption. This projectaddresses these gaps by co-designing a culturally grounded, evidence-based integratedyoga module with traditional practitioners and biomedical experts, ensuring alignmentsof traditional wisdom with modern science. By validating yoga’s efficacythrough biochemical and psychosocial metrics, it advances mechanisticunderstanding of mind-body interventions. Through feasibility testing and asubsequent randomized controlled trial (RCT), the project will explore yoga’simpact on prostaglandins, cytokines, cortisol, and progesterone, elucidatinghow it disrupts PD pathophysiology. This translational approach not onlystrengthens yoga’s credibility as an evidence-based therapy but also informsbroader applications for inflammatory and stress-related conditions.Additionally, the intervention empowers women to participate fully in academicand professional spheres as primary dysmenorrhea disproportionately impactsyoung women during critical educational and career-building years.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-26
• Study Start: 2025-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protaglandins	At Baseline and after 8 week of intervention
Progestrone	At Baseline and after 8 week of intervention
Interluekin(IL6 and IL 1 beta) and Pain intensity	At Baseline and after 8 week of intervention
TNF alpha	At Baseline and after 8 week of intervention

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Swami Kuvalayananda Kaksa, Department of Yoga; 🇮🇳 Ajmer, RAJASTHAN, India

Swami Kuvalayananda Kaksa, Department of Yoga

🇮🇳Ajmer, RAJASTHAN, India

Dr Sanjib Kumar Patra

Principal investigator

08618142265

sanjib.patra@curaj.ac.in