| CTRI Number |
CTRI/2024/03/063535 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga among Women with Primary Dysmenorrhea |
|
Scientific Title of Study
|
Effect of Yoga Intervention on Pain, Psychological Factors, Quality of Sleep, and Quality of Life among Women with Primary Dysmenorrhea – Randomized Controlled Trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha P Shetty |
| Designation |
PhD Scholar |
| Affiliation |
Centre for Integrative Medicine and Research, MAHE Manipal [CIMR] |
| Address |
Room No - 1 Division of Yoga Centre for Integrative Medicine and
Research, Madhav Nagar, Manipal Academy of Higher Education,
Manipal [MAHE]
Udupi
KARNATAKA
576104
India |
| Phone |
8546941321 |
| Fax |
|
| Email |
deeksha1.doympl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Neetinakumar J Patil |
| Designation |
Associate Professor |
| Affiliation |
Centre for Integrative Medicine and Research, MAHE Manipal [CIMR] |
| Address |
Room No - 1 Division of Yoga Centre for Integrative Medicine and
Research, Madhav Nagar, Manipal Academy of Higher Education,
Manipal [MAHE]
Udupi
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neetinakumar J Patil |
| Designation |
Associate Professor |
| Affiliation |
Centre for Integrative Medicine and Research, MAHE Manipal [CIMR] |
| Address |
Room No - 1 Division of Yoga Centre for Integrative Medicine and
Research, Madhav Nagar, Manipal Academy of Higher Education,
Manipal [MAHE]
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, [MAHE] |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Division of Yoga, Centre for Integrative Medicine and Research
[CIMR-Yoga], Manipal Academy of Higher Education, Manipal,
[MAHE] |
| Type of Sponsor |
Other [Private / Deemed to be University (Institute of Eminence)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Deeksha P Shetty |
PhD Scholar
Division of Yoga,
The Centre for Integrative Medicine and Research (CIMR), MAHE, Manipal
KARNATAKA
576104
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetinakumar J Patil |
Kasturba Hospital |
Room No1, 1st Floor, Dormitory
building (Opp. Artificial
Limb Center)
Division of Yoga
Centre for Integrative Medicine and Research, Manipal, India [CIMR]
Udupi
KARNATAKA |
9886211008
ayushnitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Walking with Standard Care |
Walking (Normal speed) 45 minutes per session, 5 session per week for 12 weeks |
| Intervention |
Yoga Therapy adjuvant to Standard care
|
Yoga Session comprising of
1. Suryanamaskara
2. Asana
3. Pranayama
4. Yoga Nidra
Each Session duration- 45 Minutes. Frequency - 5 days
a week, for 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Visual Analog Scale between 4 to 7 |
|
| ExclusionCriteria |
| Details |
1. Women with secondary dysmenorrhea (Examples; Fibroids, endometriosis)
2. Women with conditions that limit their ability to exercise, such as joint, mobility,
3. muscle, or bone problems
4. Mental illnesses.
5. Women who had abdominal surgery.
6. Professional athletes or active sports participants.
7. Those suffering from Chronic diseases such as diabetes, hypertension, cardiac
8. Disease and infectious disease, or any other medication.
9. Women using intrauterine devices, women on OCs, and hormonal therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain(VAS)
Prostaglandin F2α(PGF2α) |
Day 0
Week 12/ 3rd Cycle
Week 24/ 6th Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality Of Life(WHOQOL)
Pittsburgh Sleep Quality Index(PSQI)
Depression, Anxiety, Stress(DASS-21)
Body Mass Index(BMI)
Dysmenorrhea Questionnaire(DYSQ) |
Day 0
Week 12
Week 24 |
| Electro Photon Imaging [EPI] |
Day 0
Week 4/ 1st Cycle
Week 8/ 2nd Cycle
Week 12/ 3rd Cycle
Week 16/ 4th Cycle
Week 20/ 5th Cycle
Week 24/ 6th Cycle |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
• Dysmenorrhea is a common condition that is highly prevalent in young females. Extreme pain is the main reason why working
women and college girls experience periodic short-term absences. In addition to pain, it has an impact on mental health and quality of life. Antispasmodic and other painkillers were widely used, but mental health and quality of life were not an integral part of the stand care at present. Yoga is an ancient mind-body medicine emerging as a holistic/complementary medicine/therapy. In the present study, an attempt is made to evaluate the effect of an integrated yoga module in addition to standard care for holistic management of primary dysmenorrhea. |