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CTRI Number  CTRI/2025/12/098442 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing The Effects Of Yoga And Core Strengthening Exercises On, Distress And Quality Of Life Among Females With Menstrual Pain 
Scientific Title of Study   EFFECTS OF CORE STRENGTHENING EXERCISES AS COMPARED TO YOGA ON DISTRESS AND QUALITY OF LIFE AMONG FEMALES WITH MENSTRUAL PAIN 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavishya B SHETTY 
Designation  Post graduate student 
Affiliation  Hosmat hospital educational institutes college of physiotherapy 
Address  Hosmat hospital educational institute, college of physiotherapy ( DEPARTMENT OF PHYSIOTHERAPY), room no 1 sy no 52,bethel campus ,bethel street , near laggere main road , preethi nagar , laggere , bangaluru

Bangalore
KARNATAKA
560058
India 
Phone  8618649392  
Fax    
Email  bhavishyashetty881@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Purnima Singh 
Designation  Principal 
Affiliation  Hosmat hospital educational institutes, college of physiotherapy 
Address  Hosmat hospital educational institute, college of physiotherapy ( DEPARTMENT OF PHYSIOTHERAPY), room no 1 sy no 52,bethel campus ,bethel street , near laggere main road , preethi nagar , laggere , Bengaluru

Bangalore
KARNATAKA
560058
India 
Phone  9886367792  
Fax    
Email  purnimasingh29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Purnima Singh 
Designation  Principal 
Affiliation  Hosmat hospital educational institutes, college of physiotherapy 
Address  Hosmat hospital educational institute, college of physiotherapy ( DEPARTMENT OF PHYSIOTHERAPY), room no 1 sy no 52,bethel campus ,bethel street , near laggere main road , preethi nagar , laggere , Bengaluru

Bangalore
KARNATAKA
560058
India 
Phone  9886367792  
Fax    
Email  purnimasingh29@gmail.com  
 
Source of Monetary or Material Support  
Hosmat educational institute college of physiotherapy 
 
Primary Sponsor  
Name  Dr Bhavishya B Shetty 
Address  Hosmat hospital educational institute, college of physiotherapy ( DEPARTMENT OF PHYSIOTHERAPY), room no 1 sy no 52,bethel campus ,bethel street , near laggere main road , preethi nagar , laggere , Bengaluru 
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 Bhavishya B Shetty  Hosmat Group of institutions,college of physiotherapy  Hosmat hospital educational institute, college of physiotherapy ( DEPARTMENT OF PHYSIOTHERAPY), room no 1 sy no 52,bethel campus ,bethel street , near laggere main road , preethi nagar , laggere , Bengaluru
Bangalore
KARNATAKA 		 8618649392

bhavishyashetty881@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Review board of ethics committee, Hosmat hospital education institiuition  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  dysmenorrhea 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  core strengthening exercises  Total duration is sixty minutes Before commencement of exercise a brief period five to seven minutes of warm up including jumping jacks, high leg kicks, lunges and stretching. Core strengthening exercises include Bicycle crunches, Abdominal curls, Standing trunk rotations, Side bends, Pelvic bridges, Mountain climbers. After exercise a cool down period of five minutes including jumping jacks,hig leg kicks,upper body and back stretch and relaxing position.  
Comparator Agent  Yoga  Total duration is sixty minutes Surya Namaskara for 10 complete cycles, 12 postures each with coordinated breathing for total 15 minutes. Followed immediately by 5 minutes of Shavasana relaxation. Three Yoga Poses Bhujangasana, Marjariasana, and Matsyasana for 5 cycles of each pose, performed sequentially over 10 minutes. Yoga Nidra that is Psychic Sleep for 30 minutes of guided relaxation & meditation in Shavasana Includes sequential steps: resolve, rotation of consciousness, awareness of breath or body sensations, and visualization. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Females with menstrual pain of age 15 to 25
Willingness to refrain from initiating any new pelvic core exercise or yoga practice outside the study protocol during intervention period
Regular menstrual cycles 21 -35 days for greater than or equal to six months
 
 
ExclusionCriteria 
Details  Diagnosed with menstrual pain due to secondary pathology or pelvic pathology.
Use of hormonal contraceptives or other medication affecting menstrual cycle
Any chronic pain syndrome or systemic disease eg fibromyalgia
• Any psychiatric illness requiring pharmacotherapy(eg:major depression, anxiety disorders) that could confound distress or quality of life

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
medi-q
sf-36 		 pre and post intervention that is after twelve weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   15/12/2025 
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="9"
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   Menstrual pain frequently impairs activity, mood and academic participation in young women. This trial will compare the effectiveness of a supervised core strengthening program versus a structured yoga regimen in reducing menstrual distress and improving health-related quality of life among female college students with menstrual pain.This study offer low-cost, accessible alternatives to medication for menstrual pain, we will compare the effects of core strengthening versus yoga on symptom distress and daily functioning in young women with primary dysmenorrhea.Eligible participants will be put to one of the two interventions and will perform supervised sessions three times weekly for 12 weeks. The outcome change is measured by the Menstrual Distress Questionnaire (MEDI-Q) from baseline to 12 weeks. Another outcome includes change in SF-36 quality-of-life scores, MEDI-Q subindices (symptom burden and distress indices), functional impact on work/education/activities, intervention adherence, and adverse events. Outcomes will be assessed at baseline and at the end of the 12-week intervention; adherence and adverse events will be recorded throughout.Findings will inform non-pharmacological physiotherapy and mind–body treatment options for menstrual pain in young women and may guide scalable, low-cost interventions in college health settings. 
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