| CTRI Number |
CTRI/2025/07/090072 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Yogic management of Dysmenorrhea ,Depression and Emotional Maturity in Adolescent Girls. |
|
Scientific Title of Study
|
Effect of Yogic Intervention on Dysmenorrhea among Adolescent Girls. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenakshi Saraf |
| Designation |
Ph.D. Scholar |
| Affiliation |
Hemvati Nandan Bahuguna Garhwal University (A Central University) |
| Address |
Department of Naturopathy and Yoga, Chauras Campus ,Hemvati Nandan Bahuguna Garhwal University, Srinagar Garhwal , Uttarakhand
Garhwal
UTTARANCHAL
246174
India |
| Phone |
7302149372 |
| Fax |
|
| Email |
meenakshisaraf2108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuja Rawat |
| Designation |
Associate Professor |
| Affiliation |
Hemvati Nandan Bahuguna Garhwal University (A Central University) |
| Address |
Department of Naturopathy and Yoga, Chauras Campus ,Hemvati Nandan Bahuguna Garhwal University, Srinagar Garhwal , Uttarakhand
Garhwal
UTTARANCHAL
246174
India |
| Phone |
8053347946 |
| Fax |
|
| Email |
Yogahnbgu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Rawat |
| Designation |
Associate Professor |
| Affiliation |
Hemvati Nandan Bahuguna Garhwal University (A Central University) |
| Address |
Department of Naturopathy and Yoga, Chauras Campus ,Hemvati Nandan Bahuguna Garhwal University, Srinagar Garhwal , Uttarakhand
Garhwal
UTTARANCHAL
246174
India |
| Phone |
8053347946 |
| Fax |
|
| Email |
Yogahnbgu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Meenakshi Saraf |
| Address |
Department of Naturopathy and Yoga, Chauras Campus , Hemvati Nandan Bahuguna Garhwal University(A central University),Srinagar, Garhwal 246174, 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 |
| Sumanlata Panwar |
Government Girls Inter College |
Srinagar Khirsu , Pauri Garhwal
Garhwal
UTTARANCHAL |
9412982727
sumanpanwar27@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,HNBGU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dysmenorrhea(Menstrual Pain) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Group doing regular activity |
| Intervention |
Yogic Intervention |
A three-month yoga intervention will be provided, followed by a one-month follow-up to assess the sustained effects. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1. This study will include Adolescent students having mild, moderate and severe menstrual pain.
2. Students between the ages of 13- 19 years.
3. Only school-going girls will be included.
4. Girls participating willingly will be included.
|
|
| ExclusionCriteria |
| Details |
1. Adolescent girls having any kind of health complication and undergoing medication.
2. Physiological and psychological complications.
3. Married females will not be included.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progesterone level ,Pain Severity |
At baseline (pre-intervention) and at the end of 12 weeks (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Emotional Maturity |
At baseline (pre-intervention), at the end of 12 weeks (post-intervention), & at 16 weeks (1-month follow-up). |
| Depression |
At baseline (pre-intervention), at the end of 12 weeks (post-intervention), & at 16 weeks (1-month follow-up). |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is a randomized, parallel-group, controlled trial designed to
assess the effectiveness of a 90-day structured yogic intervention on
dysmenorrhea among adolescent school-going girls aged 13–19 years. The trial was
conducted at Government Girls Inter College (GGIC), Srinagar, Garhwal,
Uttarakhand, India.
The initially calculated sample size was 82 participants, determined using
G*Power analysis with a 20% anticipated dropout rate. However, due to limited
parental consent, a total of 70 participants meeting the inclusion criteria
(mild to severe dysmenorrhea; Verbal Multidimensional Scoring System [VMSS]
score 1–3) were enrolled in the study. Participants were randomly assigned into
two groups: Experimental group (n=35) and Control group (n=35).
The experimental group underwent daily 60-minute structured yogic sessions
for 90 consecutive days, while the control group continues their routine
activities without intervention.
The primary outcome measures include serum progesterone levels (assessed
through venous blood sampling and analyzed at an authorized pathology
laboratory) and severity of dysmenorrhea measured using the Verbal
Multidimensional Scoring System (VMSS). Serum progesterone levels were
evaluated at baseline and post-intervention, whereas VMSS scores are assessed
at baseline, post-intervention, and one-month follow-up.
Secondary outcome measures included depression (assessed using the Mental
Depression Scale) and emotional maturity (assessed using the Emotional Maturity
Scale), measured at baseline, post-intervention, and one-month follow-up.
The study aimed to evaluate yoga as a holistic, non-pharmacological
intervention for managing both physiological and psychological symptoms
associated with dysmenorrhea among adolescents. |