| CTRI Number |
CTRI/2025/12/098935 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for Menstrual Cramps: A Study on Young Girls |
|
Scientific Title of Study
|
EFFECT OF CUSTOMIZED YOGA PROTOCOL ON PRIMARY DYSMENORRHEA IN YOUNG GIRLS: A RANDOMIZED
CONTROL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Patel |
| Designation |
Ph.D Scholar |
| Affiliation |
Swami Rama Himalayan University Swami Ram Nagar, Jolly Grant, Dehradun, Uttarakhand. |
| Address |
School of Yoga Sciences,Swami Rama Himalayan University
Swami Ram Nagar, Jolly Grant,
Dehradun, Uttarakhand, 248016
Dehradun
UTTARANCHAL
248016
India |
| Phone |
8445008358 |
| Fax |
|
| Email |
pateldiksha112000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchira Nautiyal |
| Designation |
Head and professor |
| Affiliation |
Swami Rama Himalayan University Swami Ram Nagar, Jolly Grant, Dehradun, Uttarakhand. |
| Address |
Department of Obstetrics and Gynaecology), Swami Rama Himalayan University
Swami Ram Nagar, Jolly Grant,
Dehradun, Uttarakhand, 248016
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9410767892 |
| Fax |
|
| Email |
ruchiranautiyal@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subodh Saurabh Singh |
| Designation |
Assistant Professor |
| Affiliation |
Swami Rama Himalayan University Swami Ram Nagar, Jolly Grant, Dehradun, Uttarakhand, 248016 |
| Address |
School of Yoga Sciences,Swami Rama Himalayan University
Swami Ram Nagar, Jolly Grant,
Dehradun, Uttarakhand, 248016
Dehradun
UTTARANCHAL
248016
India |
| Phone |
8882423186 |
| Fax |
|
| Email |
subodhsingh@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan University |
| Address |
Swami Rama Himalayan University Swami Ram Nagar, Jolly Grant Dehradun Uttarakhand India Pincode-248016 |
| Type of Sponsor |
Other [Private 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 |
| Dr Ruchira Nautiyal |
Swami Rama Himalayan University Swami Ram Nagar, Jolly Grant, Dehradun, Uttarakhand, 248016 |
Department Of Obstetrics and Gynaecology
Dehradun
UTTARANCHAL |
9410767892
ruchiranautiyal@srhu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Swami Rama Himalayan University, Swami Ram Nagar, dehradun, 248140 |
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 |
Usual care |
Usual care |
| Intervention |
Yoga Protocol |
Opening Prayer -2 Minute
Matsyasana -2 Minute
Vajrasana -2 Minute
Ushtrasana -2 Minute
Bhujangasana -2 Minute
Marjariasana -3 Minute
Diaphragmatic Breathing -10 Minute
Nadishodhan Pranayama -5 Minute
Bhramari Pranayama -5 Minute
Closing Prayer -2 Minute |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Young girls with primary dysmenorrhea
2. who are willing to give concent
3. Age between 15-25 years
4. Who has an android phone |
|
| ExclusionCriteria |
| Details |
1. Associated secondary dysmenorrhea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain intensity,
Quality of Life
|
Baseline and after 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
30/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This Randomized Controlled Study is focused on evaluating the impact of yoga on primary dysmenorrhea among the 166 young girls age range between 15-25 at Swami Rama Himalayan University. The Pain intensity will be measured by Visual Analogue Scale and Quality Of Life will be measured by SF-36 questionnaire. The participant will be divided into experimental and control group 83 in each group and the intervention will be given to experimental group for 12 weeks. |