| CTRI Number |
CTRI/2026/02/104146 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the benefits of yoga in women with premenstrual syndrome |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of yoga module in the management of premenstrual syndrome |
| 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 Megha |
| Designation |
Pg Scholar |
| Affiliation |
Institute for ayurved studies and research kurukshetra |
| Address |
Opd no 2 Pg department of swasthvritta and yoga
Institute for ayurved studies and research
Shri krishna Ayush university
Sector 8 umri road
Kurukshetra
Haryana
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9518160265 |
| Fax |
|
| Email |
meghakundu59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital S Mahadik |
| Designation |
Professor Department of Swasthvritta and Yoga |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room No 64 Pg Department of Swasthvritta and Yoga Institute for Ayurved Studies and Research Sector 8 Umri Road Kurukshetra Haryana 136118 India
Kurukshetra
Haryana
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9468475757 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha |
| Designation |
Pg Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Opd No 2 Pg Department of Swasthvritta and Yoga Institute for Ayurved Studies and Research
Shri Krishna Ayush University
Sector 8 Umri Road Kurukshetra
Kurukshetra
Haryana
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9518160265 |
| Fax |
|
| Email |
meghakundu59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Dr Megha |
| Address |
OPD No 2 Department of Swasthavritta and Yoga Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 India |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Megha |
Shri Krishna ayush University and hospital |
OPD No 2 Department of Swasthavritta and Yoga Institute for ayurved studies and research,Haryana 136118,india
Kurukshetra
HARYANA |
9518160265
meghakundu59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAU kurukshetra IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD 10 :Premenstrual syndrome
N94.3 |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yoga module will be given to the women having PMS symptoms for 45 days that include suksham vyayam,asanas,pranayam and relaxation for 45 minutes., Ritucarya: Not applicable , Acara Rasayana:Not applicable , Other:Not applicable , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)No history of any mental disease.
2)No history of any joint motion muscle bone disease that reduce ability to exercise.
3)Having regular menstrual cycle of 21 to 35 days.
4) Having symptoms of PMS (Pre menstrual syndrome). |
|
| ExclusionCriteria |
| Details |
1)Not able to tolerate physical exercise.
2)Having any gynecological surgery or disease like pcos, endometriosis.
3)Any Chronic disease like diabetes, hypertension, cardiac disease.
4) Irregular menses.
5) Using intrauterine devices, hormonal therapy,ocp.
6) Pregnant women.
7) Diagnose case of psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of yoga in the reduction of PMS symptoms. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/03/2026 |
| 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
|
Premenstrual Syndrome (PMS) is a common condition affecting women of reproductive age, characterized by physical symptoms such as abdominal pain, breast tenderness, bloating, and fatigue, along with psychological symptoms like irritability, mood swings, anxiety, and depression. These symptoms occur during the luteal phase of the menstrual cycle and significantly affect quality of life. This clinical study aims to evaluate the effectiveness of a structured yoga module in reducing the severity of PMS symptoms. The study will include women aged 18–35 years diagnosed with PMS. Participants will undergo a daily yoga program consisting of selected asanas, pranayama, and meditation practices for approximately 45 minutes over two consecutive menstrual cycles. Assessment will be done using standardized PMS scoring scales before and after intervention. Statistical analysis will compare pre- and post-treatment results. The study is expected to demonstrate that yoga is a safe, cost-effective, and non-pharmacological approach that helps reduce both physical and psychological symptoms of PMS by improving hormonal balance, reducing stress, and enhancing overall well-being. |