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CTRI Number  CTRI/2024/11/076371 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Parnayama on depression, stress, anxiety and quality of life in females with PCOD  
Scientific Title of Study   Efficacy of Pranayama on depression, stress, anxiety and quality of life in females with diagnosed polycystic ovarian syndrome: 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 Umisha Madhur Rathi  
Designation  Masters of Community physiotherapy student  
Affiliation  K J Somaiya College of Physiotherapy  
Address  K J Somaiya College of Physiotherapy Womens health and pelvic floor rehabilitation Community department OPD number 25 Ayurvihar eastern express highway Sion Mumbai 400022 Maharashtra

Mumbai
MAHARASHTRA
400022
India 
Phone  9922579369  
Fax    
Email  umisha.rathi@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Pothiraj Pitchai 
Designation  Professor and Head of Department  
Affiliation  K J Somaiya College of Physiotherapy Sion 
Address  K J Somaiya College of Physiotherapy Womens health and pelvic floor rehabilitation Community department OPD number 25 Ayurvihar eastern express highway Sion Mumbai 400022 Maharashtra

Mumbai
MAHARASHTRA
400022
India 
Phone  9769497441  
Fax    
Email  pothiraj@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pothiraj Pitchai  
Designation  Professor and Head of Department  
Affiliation  K J Somaiya College of Physiotherapy Sion  
Address  K J Somaiya College of Physiotherapy Womens health and pelvic floor rehabilitation Community department OPD number 25 Ayurvihar eastern express highway Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9769497441  
Fax    
Email  pothiraj@somaiya.edu  
 
Source of Monetary or Material Support  
K J Somaiya College of Physiotherapy  
 
Primary Sponsor  
Name  K J Somaiya College of Physiotherapy Sion  
Address  K J Somaiya College of Physiotherapy Womens health and pelvic floor rehabilitation OPD number 25 Ayurvihar eastern express highway Sion Mumbai 400022 Maharashtra  
Type of Sponsor  Research institution and hospital 
 
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 Umisha Rathi   K J Somaiya College of Physiotherapy   K J Somaiya College of Physiotherapy Womens health and pelvic floor rehabilitation Community department OPD number 25 Ayurvihar eastern express highway Sion Mumbai 400022 Maharashtra
Mumbai
MAHARASHTRA 		 9922579369

umisha.rathi@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee K J Somaiya College of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Females with polycystic ovarian syndrome  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Supervised Moderate intensity continuous training (MICT)  5 min warm up period 20-min sessions of continuous moderate intensity exercise sessions of cycling at 60-75% of maximum heart rate. 5 min of cool down period. The protocol will be taken thrice a week for 6 weeks 
Intervention  Supervised Pranayama techniques   The supervised Pranayama sessions will be for 30 minutes. These sessions will include 6 pranayama techniques which are Kapalbhati, Anulom-viloma,Ujjayi, bhastrika, bhramari and last shavasana. The participants will be in upright sitting position for the five pranayama techniques and in supine lying for shavansana technique. The protocol will be taken thrice a week for six weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Females in the reproductive age group between 18-40 years who are pre diagnosed with PCOS and are fulfilling mild or moderate scoring criteria of minimum of one component in depression or stress or anxiety (DASS-21) questionnaire are included. The cut off scores for mild depression is 10-20, for anxiety is 8-14 and for stress is 15-25 
 
ExclusionCriteria 
Details  Pregnant women
Females having any acute diseases or problems of heart or lung
Undergoing active pharmacological treatment for stress, anxiety and depression  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Depression, Anxiety and Stress scale-21 items (DASS-21)
2. Health related quality of life questionnaire for women with polycystic ovarian syndrome (PCOSQOL) 		 Pre treatment assessment and after six weeks of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Sleep Quality Scale(SQS)
 		 Pre treatment assessment and after six weeks of intervention  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   08/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study focuses on evaluating the effectiveness of pranayama compared to moderate intensity continuous training (MICT) in improving mental health, sleep quality, and quality of life in women with polycystic ovarian syndrome (PCOS). Women with PCOS often experience higher levels of stress, anxiety, and depression, which can negatively affect their quality of life. While MICT is known to reduce these symptoms, many women face barriers to regular physical activity. Pranayama, a simpler and more time-efficient practice, may offer similar benefits without the side effects of medications or the challenges of daily exercise, making it a promising alternative therapy.


62 participants will be included and everyone will be given a sequential number. Then the participants will be randomly divided into two groups by computer random generated number list.
Each group will have 31 participants each.
 Group A will be the intervention group receiving a structured Pranayama protocol including 5 Pranayama and Shavasana
Group B will be a control group receiving MICT
The protocol will be of 30 minutes thrice a week for 6 weeks.


Depression, anxiety and stress scale-21 items (DASS-21), Health related quality of life questionnaire for women with PCOS (PCOSQOL) and Sleep quality scale(SQS) are the outcome measures which will be taken before and 6 weeks of intervention.
 
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