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CTRI Number  CTRI/2024/12/078195 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of yoga on Menstrual cramps 
Scientific Title of Study   Role Of Specific Yogic Practices Towards Management Of Primary Dysmenorrhea :A Randomized Control Clinical 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  Km Roopa Sharma 
Designation  Ph.D.Scholar 
Affiliation  Amity University sector 125 , Noida 
Address  Amity institute of Indian system of Medicine, Block F3,Amity university Sector 125, Noida Uttar Pradesh.

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  8433090338  
Fax    
Email  km.sharma10@s.amity.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenakshi Pandey  
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda, sarita vihar,Delhi 
Address  Department of Stree Rog & Parsuti Tantra, All India Institute of Ayurveda, Delhi,

South
DELHI
110076
India 
Phone  9984549998  
Fax    
Email  drmeenakshipathak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Garima Jaiswal 
Designation  Assistant Professor 
Affiliation  Amity University ,sector 125 , Noida 201303 
Address  Amity institute of Indian system of Medicine, Block F3,Amity university Sector 125, Noida Uttar Pradesh.

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  8899799508  
Fax    
Email  gjaiswal1@amity.edu  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda ,Delhi 110074 
 
Primary Sponsor  
Name  km Roopa Sharma 
Address  Amity University, sector 125 ,NOida 
Type of Sponsor  Other [UGC NET JRF (JUNIOUR RESEARCH FELLOWSHIP)] 
 
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 Meenakshi Pandey  All India Institute Of Ayurveda   OPD no 203,Department of Stri Roga and Parsuti Tantra, All India Institute of Ayurveda, Sarita Vihar ,Delhi
South
DELHI 		 9984549998

drmeenakshipathak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of All India Institute of Ayurveda.  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  Yogic Practices  Trail group will be practice Yoga for three months 
Comparator Agent  yoga intervention   3 sets of Asanas for three Months 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1.Individuals between the age group of 14 -30 years.
2.Patients come with chief complaint of pain with irregular menses.
3.Patients having scanty or average amount of menses along with associated symptoms:
4.Patients suffering from Dysmenorrhea for more than 3 consecutive cycles.
5.Individuals willing to take part in the study.
 
 
ExclusionCriteria 
Details  1.Patients suffering from systemic chronic illness.
2.Those diagnosed with Secondary Dysmenorrhea
3.Patients who marked severe pain in VAS scale.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant change in pain intensity and duration, collect samples   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Significant change in Menstruation related symptoms
2.Serum Prostaglandin
3.Inhence Quality of Life
 		 3 months 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   27/12/2024 
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="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  

Project Summary: Role of Specific Yogic Practices in Managing Primary Dysmenorrhea

This project investigates the efficacy of a structured yoga intervention in alleviating pain and enhancing the quality of life (QOL) for women suffering from primary dysmenorrhea, a prevalent gynecological condition characterized by painful menstruation without underlying pathology. The study also examines the intervention’s effect on biochemical markers such as serum prostaglandin levels.

Study Objectives

  1. Primary Objective: To assess the impact of specific yogic practices on pain relief in primary dysmenorrhea.
  2. Secondary Objectives:
    • To evaluate improvements in QOL using standardized tools (WHOQOL-BREF).
    • To examine changes in menstrual symptoms and serum prostaglandin levels.

Methodology

Design: Randomized controlled clinical trial with 130 participants, split equally into intervention and control groups.

Participants: Females aged 14–30 years with primary dysmenorrhea for at least three cycles, experiencing mild to moderate pain.Interventions:

Trial Group: A tailored yoga protocol including specific asanas, pranayama, and mudras.

Control Group: A standardized set of three asanas (Marjaryasana, Bhujangasana, Matsyasana).

  • Duration: 3 months with a 1-month follow-up.
  • Assessment Tools:
    • Visual Analog Scale (VAS) for pain.
    • WHOQOL-BREF for QOL evaluation.
    • Serum prostaglandin measurement using ELISA.

Expected Outcomes

  • Primary: Reduction in pain intensity and duration.
  • Secondary:
    • Decreased prostaglandin levels.
    • Improvement in associated symptoms (e.g., nausea, fatigue).
    • Enhanced QOL metrics.

Significance

The project addresses a critical gap in non-pharmacological interventions for managing menstrual pain. By exploring yoga’s therapeutic potential, it aims to offer a cost-effective, accessible, and holistic alternative to conventional treatments for primary dysmenorrhea.

Ethical Considerations

  • Approved by the Institutional Ethics Committee.
  • Informed consent from all participants.
  • Confidentiality maintained through anonymized data.

This study is expected to generate evidence supporting yoga as an effective complementary treatment for dysmenorrhea, contributing to the broader acceptance of traditional practices in modern medicine.

 
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