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
|
|
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
|
|
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. |