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CTRI Number  CTRI/2023/09/057303 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Physiotherapy (Including Yoga)]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effects of Yoga Therapy and Pilates Training in Premenstrual Syndrome 
Scientific Title of Study
Modification(s)  
A Study on Comparative Effects of Yoga Therapy and Pilates Training on Cardiopulmonary, Psychological Parameters and Quality of Life in Premenstrual Syndrome 
Trial Acronym  PMS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika 
Designation  Research Scholar 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology

Hisar
HARYANA
125001
India 
Phone  7027342080  
Fax    
Email  monika76738@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalindi Dev 
Designation  Assistant Professor 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology  
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology

Hisar
HARYANA
125001
India 
Phone  9996323938  
Fax    
Email  kalindiphysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalindi Dev 
Designation  Assistant Professor 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology  
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology

Hisar
HARYANA
125001
India 
Phone  9996323938  
Fax    
Email  kalindiphysio@gmail.com  
 
Source of Monetary or Material Support  
Monika (Research Scholar) Department of Physiotherapy Guru Jambheshwar University of Science and Technology New Delhi-Sirsa Highway Hisar-125001 Haryana 
 
Primary Sponsor  
Name  Guru Jambheshwar University of Science and Technology 
Address  New Delhi-Sirsa Highway Hisar-125001 Haryana India 
Type of Sponsor  Other [Government University] 
 
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 
Monika  Guru Jambheshwar University of Science and Technology  Room No: 109 Research Lab, Department of Physiotherapy Hisar Haryana
Hisar
HARYANA 
7027342080

monika76738@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N943||Premenstrual tension syndrome,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Group A  Yoga Therapy (45 minutes); Breathing (5 minutes) Yoga asanas (30 minutes) Relaxation (10 minutes) for 18 sessions carried out over 6 weeks 
Intervention  Group B  Pilates Training (45 minutes); Warm up (5 minutes) Pilates exercises (30 minutes) Relaxation (10 minutes) for 18 sessions carried out over 6 weeks 
Comparator Agent  Group C  Pelvic Floor Strengthening Exercises (45 minutes); Warm up (5 minutes) Exercises (30 minutes) Relaxation (10 minutes) for 18 sessions carried out over 6 weeks  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  • Subjects with PMS according to the PSST questionnaire
• Having regular menstrual periods
• Being non athletic for duration of 3 months
• Moderate & severe depression, anxiety and stress score 
 
ExclusionCriteria 
Details  • Already had participating in regular exercises program for the last 6 months.
• History of not using any oral contraceptives, pharmaceutical drugs, or herbal remedies.
• Not suffering from any orthopaedics problems like arthritis, spinal tumours and
congenital spinal abnormalities.
• Any associated neurological problems like significant cognitive defects etc.
• Any associated pathological disease and malignant disease.
• Any associated co-morbidity like cardiac and pulmonary disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• Severity of symptoms by PSST (Premenstrual symptoms screening tool)
• Blood pressure & heart rate
• Respiratory parameters
• Depression, anxiety & stress
• Quality of life  
The participants will be assessed at baseline
(Pre intervention data), & after 6 weeks
(post-intervention) & after one month
(follow-up) . There will be 18 session in each
group (three session per week for 6 weeks).
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2023 
Date of Study Completion (India) 26/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 26/03/2025 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Ranga, M., & Dev, K. (2024). The effect of yoga therapy in premenstrual syndrome: A systematic review and meta-analysis of randomized controlled trials. Journal of Obstetrics and Gynaecology Canada. Advance online publication. https://doi.org/10.1016/j.jogc.2024.102579 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Premenstrual syndrome is a clinical illness that causes recurring emotional and physical symptoms even without underlying biological disease. These symptoms may appear five days before menses and disappear within four days of the start of the menstrual cycle. Women who have PMS report lower reported work-related quality of life and health-related quality of life. PMS may lead to depression and higher psychiatric comorbidity. Between 80% and 90% of women have been reported to have PMS with the 20–45-year-old age range showing the highest prevalence. Premenstrual syndrome makes it more likely for women to experience depression, low self esteem and an energy deficit and with mild to severe PMS, a population based study found that the prevalence of major depression was 11.3% and 24.6%, respectively. Progesterone, Oestrogen and irregular hormone profiles have been linked to menstrual problems. Numerous PMS-related issues may impair a woman’s ability to function physically, psychologically and in her social life. Women’s lives are impacted by PMS due to insufficient work hours, absenteeism and decreased productivity. Because it interferes with daily activities and negatively impacts women’s health, PMS is a condition that needs proper treatment. However, as pharmacological treatments for PMS can have adverse reactions and long-term side effects such as fatigue, headaches, rage, sadness and non-pharmacological methods are more widely used. There is evidence that yoga has positive effects on the sympathetic nervous system while also having a detrimental influence on the hypothalamic pituitary adrenal axis. Yoga is a successful way to prevent and control disease, as well as to improve overall health. Changing autonomic functioning and psychological states during the premenstrual phase is largely facilitated by yoga. Yoga also has a positive impact on the body’s harmful secretions and relief to women experiencing cramps and gives them a comfortable way of life. Yoga significantly reduces PMS symptoms and influences emotional, physical and behavioural factors and suggesting that yoga should be used to treat PMS. A Pilates training programmed can effectively reduce the physical, psychological, and behavioural difficulties related with the more typical PMS. Pilates exercises also enhances the quality of life, sleep quality and perception of health in the elderly, improves psychological condition and provides tension control for those with hypertension. The participants will be randomly divided into three groups: Group A: Treatment protocol in group A will be yoga therapy. Group B: Treatment protocol in group B will be Pilates training. Group C: Treatment protocol in group C will be control group that consist of pelvic floor strengthening exercises. For this study subjects will be selected from various hospitals and communities. Subjects of premenstrual syndrome will be screened on the basis of inclusion and exclusion criteria and will be divided into 3 groups. For the participation in this study, informed consent will be taken. Pre intervention data will include analysis of blood pressure, heart rate, respiratory parameters, depression, anxiety, stress and quality of life of each participant of all the groups will be taken. The exercises protocol will be given for 6 weeks in three session/week for 45 minutes. Post intervention data will be taken after 6 weeks of all the parameters. This study will have follow up of one month with same subjects and data for all the parameters will be collected again.
 
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