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CTRI Number  CTRI/2025/07/090803 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 13/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   INFLUENCE OF YOGA ON INDIVIDUALS WITH DYSMENORRHEA 
Scientific Title of Study   EFFECT OF INTEGRATED YOGA MODULE ON PRIMARY DYSMENORRHEA INDIVIDUALS - 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  Dr PATHMAPRIYA T R 
Designation  MD SCHOLAR 
Affiliation  DEPARTMENT OF YOGA AND THERAPEUTICS 
Address  SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7448564369  
Fax    
Email  pathmapriya000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PATHMAPRIYA T R 
Designation  MD SCHOLAR 
Affiliation  DEPARTMENT OF YOGA AND THERAPEUTICS 
Address  SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7448564369  
Fax    
Email  pathmapriya000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SHIVAPRASAD K 
Designation  DEAN DIVISION OF YOGA THERAPEUTICS 
Affiliation  SDM COLLEGE OF NATUROPATHY AND YOGI SCIENCES 
Address  SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9731854585  
Fax    
Email  drshivapshetty70@gmail.com  
 
Source of Monetary or Material Support  
SDM EDUCATIONAL INSTITUTIONS UJIRE, BELTHANGADY TALUK, DAKSHINA KANNADA, KARNATAKA, INDIA - 574240 
 
Primary Sponsor  
Name  Dr PATHMAPRIYA T R 
Address  SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA 
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 PATHMAPRIYA  SDM YOGA AND NATURE CURE HOSPITAL, SHANTIVANA  CENTER OF EXCELLENCE, SDM YOGA AND NATURE CURE HOSPITAL, SHANTIVANA, DHRMASTHALA, DAKSHINA KANNADA - 574216
Dakshina Kannada
KARNATAKA 
7448564369

pathmapriya000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES INSTITUTIONAL ETHICAL 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 
Comparator Agent  NO INTERVENTION  THE CONTROL GROUP WONT RECEIVE ANY INTERVENTION. 
Intervention  YOGA  SUBJECTS WILL UNDERGO YOGA PRACTICE FOR 45 MINTUES FOR 5 DAYS IN A WEEK FOR A PERIOD OF 3 MONTHS. IT CONTAINS OF OM CHANTING FOLLOWED BY SUKSHAMA VYAYAMA, ASANAS, PRANAYAMA, YONI MUDRA AND MOOLA BANDHA. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1. Diagnosed with primary dysmenorrhea
2. The cycle should be regular
3. Not currently engaged in regular yoga practice 
 
ExclusionCriteria 
Details  1. Pregnancy
2. Recent Abdominal surgery
3. Current Use of Hormonal Treatments
4. Regular Yoga Practitioners
5. Psychiatric disorders: Severe Psychiatric disorders (Example: Severe Depression. Schizophrenia)
6. Substance Abuse
7. Secondary Dysmenorrhea
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability (HRV)  pre and post 
 
Secondary Outcome  
Outcome  TimePoints 
1. Visual Analogue Scale
2. WaLIDD Questionnaire
3. QOL questionaire 
Pre and post 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/08/2025 
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="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  

Primary Dysmenorrhea (PD) is a common "menstrual disorder" causing pain and discomfort in young women. Conducted as a randomized controlled trial (RCT), the research involves 60 participants, divided into a yoga intervention group and a control group, over three months. Primary Dysmenorrhea (PD) is a common menstrual disorder that causes pain and discomfort in young women. This research is conducted as a randomized controlled trial (RCT) involving 60 participants divided into two groups: a yoga intervention group and a control group, over three months. The yoga intervention includes asanas (postures), pranayama (breathing exercises), yoni mudra, and moola bandha, practiced five days a week for 45 minutes per session. The effectiveness of yoga will be assessed using various methods, including pain intensity scales (Visual Analog Scale - VAS), menstrual impact questionnaires (WaLIDD), quality of life (QoL) assessments, and heart rate variability (HRV) analysis. The intervention includes asana (postures), pranayama (breathing exercises), yoni mudra, and moola bandha, practiced five days a week for 45 minutes per session. The effectiveness of yoga will be assessed using pain intensity scales (VAS), menstrual impact questionnaires (WaLIDD), quality of life (QoL) assessments, and heart rate variability (HRV) analysis. The study aims to demonstrate that yoga can significantly reduce menstrual pain, improve quality of life, and serve as a non-pharmacological treatment for primary dysmenorrhea, offering a holistic approach to women’s health.

 
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