| CTRI Number |
CTRI/2026/02/104297 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [physiotherapy including yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of yoga versus core exercise for menstrual pain. |
|
Scientific Title of Study
|
Effects of Yoga Versus Core exercise on Pain and Quality Of Life
(QOL) in Primary Dysmenorrhea 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 Nency Pandya |
| Designation |
Assistant Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
OPD No. 152, Department of Physiotherapy K M Patel Institute of Physiotherapy, Shree Krishna hospital,Gokalnagar, Karamsad, Anand
Anand
GUJARAT
388325
India |
| Phone |
9723501302 |
| Fax |
|
| Email |
ncypandya_11@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devanshi Kotecha |
| Designation |
first year PG student |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
OPD No. 152, Department of Physiotherapy K M Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand
Anand
GUJARAT
388325
India |
| Phone |
7046947999 |
| Fax |
|
| Email |
devansheekotecha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devanshi Kotecha |
| Designation |
first year PG student |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
OPD No. 152, Department of Physiotherapy K M Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand
Anand
GUJARAT
388325
India |
| Phone |
7046947999 |
| Fax |
|
| Email |
devansheekotecha@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M.patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Anand Karamsad 388325 |
|
|
Primary Sponsor
|
| Name |
Dr Nency Pandya |
| Address |
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand
GUJARAT ,388325 |
| Type of Sponsor |
Other [self-funded ] |
|
|
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 Nency pandya |
K M Patel Institute of Physiotherapy |
OPD No. 152, Department of Physiotherapy,Shree Krishna Hospital, Karamsad, Anand, Gujarat, India 388325
Anand
GUJARAT |
9723501302
ncypandya_11@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University, Karamsad, Anand, Gujarat 388325 [DHR Reg. No. EC/NEW/INST/2025/G1/0668] [OHRP Reg. No.-IRB00014178] |
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 |
CORE EXERCISE |
Group B participant will receive supervise core exercises intervention 4 sessions per week for 4 weeks pre and post outcome measures will be taken |
| Intervention |
YOGA |
group A Participants will receive supervised yoga intervention 4 sessions per week for 4 weeks. pre and post outcome measures will be taken. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Age group: 18-25 years females having Primary Dysmenorrhea with Pain on NPRS 5 or more than 5.
Females who have regular menstrual cycle.
Onset of pain within 6-12 hours after onset of menses |
|
| ExclusionCriteria |
| Details |
Any kind of other diagnosed Gynecological problem or pelvic pathology.
Females having any endocrine disorder
Females undergone any major abdominal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
DysmenQoL questionnaire
|
At baseline after enrollment of participants and at the end of intervention after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WaLIDD Score |
At baseline after enrollment of participants and at the end of intervention after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2026 |
| 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="1"
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
|
It is randomised controlled trial on Females who have symptoms of primary Dysmenorrhea with NPRS (Numerical Pain rating scale) more than or equal to 5. We assess whether the cramp-like lower abdominal pain just before or during menstruation persists in a predictable pattern. Only patients with stable, cyclical symptoms will be confirmed as eligible and if they are willing will be enrolled for studies. The participants will be recruited on the 5th day of their menstrual cycle .All the participants will be randomised through computer generated randomisation method. one group will receive yoga other one will core exercises for 4 weeks comprising 4 sessions per week. Pre and post outcome measures will be WaLIDD Score and DysmenQoL questionnaire analysis will be done using appropriate statistical tests between two groups and also in each group before and after the intervention. |