| CTRI Number |
CTRI/2025/07/090803 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
INFLUENCE OF YOGA ON INDIVIDUALS WITH DYSMENORRHEA |
|
Scientific Title of Study
|
EFFECT OF INTEGRATED YOGA MODULE ON PRIMARY DYSMENORRHEA INDIVIDUALS - 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 PATHMAPRIYA T R |
| Designation |
MD SCHOLAR |
| Affiliation |
DEPARTMENT OF YOGA AND THERAPEUTICS |
| Address |
SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
7448564369 |
| Fax |
|
| Email |
pathmapriya000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr PATHMAPRIYA T R |
| Designation |
MD SCHOLAR |
| Affiliation |
DEPARTMENT OF YOGA AND THERAPEUTICS |
| Address |
SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
7448564369 |
| Fax |
|
| Email |
pathmapriya000@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SHIVAPRASAD K |
| Designation |
DEAN DIVISION OF YOGA THERAPEUTICS |
| Affiliation |
SDM COLLEGE OF NATUROPATHY AND YOGI SCIENCES |
| Address |
SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
9731854585 |
| Fax |
|
| Email |
drshivapshetty70@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM EDUCATIONAL INSTITUTIONS UJIRE, BELTHANGADY TALUK, DAKSHINA KANNADA, KARNATAKA, INDIA - 574240 |
|
|
Primary Sponsor
|
| Name |
Dr PATHMAPRIYA T R |
| Address |
SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES, UJIRE, DAKSHINA KANNADA |
| 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 PATHMAPRIYA |
SDM YOGA AND NATURE CURE HOSPITAL, SHANTIVANA |
CENTER OF EXCELLENCE, SDM YOGA AND NATURE CURE HOSPITAL, SHANTIVANA, DHRMASTHALA, DAKSHINA KANNADA - 574216 Dakshina Kannada KARNATAKA |
7448564369
pathmapriya000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES INSTITUTIONAL ETHICAL 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 |
NO INTERVENTION |
THE CONTROL GROUP WONT RECEIVE ANY INTERVENTION. |
| Intervention |
YOGA |
SUBJECTS WILL UNDERGO YOGA PRACTICE FOR 45 MINTUES FOR 5 DAYS IN A WEEK FOR A PERIOD OF 3 MONTHS. IT CONTAINS OF OM CHANTING FOLLOWED BY SUKSHAMA VYAYAMA, ASANAS, PRANAYAMA, YONI MUDRA AND MOOLA BANDHA. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosed with primary dysmenorrhea
2. The cycle should be regular
3. Not currently engaged in regular yoga practice |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Recent Abdominal surgery
3. Current Use of Hormonal Treatments
4. Regular Yoga Practitioners
5. Psychiatric disorders: Severe Psychiatric disorders (Example: Severe Depression. Schizophrenia)
6. Substance Abuse
7. Secondary Dysmenorrhea
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability (HRV) |
pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Analogue Scale
2. WaLIDD Questionnaire
3. QOL questionaire |
Pre and post |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="0" Months="6" 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
|
Primary Dysmenorrhea (PD) is a common "menstrual disorder" causing pain and discomfort in young women. Conducted as a randomized controlled trial (RCT), the research involves 60 participants, divided into a yoga intervention group and a control group, over three months. Primary Dysmenorrhea (PD) is a common menstrual disorder that causes pain and discomfort in young women. This research is conducted as a randomized controlled trial (RCT) involving 60 participants divided into two groups: a yoga intervention group and a control group, over three months. The yoga intervention includes asanas (postures), pranayama (breathing exercises), yoni mudra, and moola bandha, practiced five days a week for 45 minutes per session. The effectiveness of yoga will be assessed using various methods, including pain intensity scales (Visual Analog Scale - VAS), menstrual impact questionnaires (WaLIDD), quality of life (QoL) assessments, and heart rate variability (HRV) analysis. The intervention includes asana (postures), pranayama (breathing exercises), yoni mudra, and moola bandha, practiced five days a week for 45 minutes per session. The effectiveness of yoga will be assessed using pain intensity scales (VAS), menstrual impact questionnaires (WaLIDD), quality of life (QoL) assessments, and heart rate variability (HRV) analysis. The study aims to demonstrate that yoga can significantly reduce menstrual pain, improve quality of life, and serve as a non-pharmacological treatment for primary dysmenorrhea, offering a holistic approach to women’s health. |