| CTRI Number |
CTRI/2024/10/075924 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Investigating positive Benefits of Yoga on college students with polycystic ovary syndrome |
|
Scientific Title of Study
|
Efficacy of Yoga Practices on Anthropometric,Biochemical, Psychological and Radiological variables Among Polycystic ovary syndrome in collge students |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Voleti venkata sucharita |
| Designation |
Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department Faculty of Yoga Science and Therapy Division 3rd floor Room No 303 No 12 Vembuliamman Koil Street West K K Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7671959343 |
| Fax |
|
| Email |
venucherry2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GRaghuram |
| Designation |
Associate Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department Faculty of Yoga Science and Therapy Division 3rd floor Room No 303 No 12 Vembuliamman Koil Street West K K Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9840691849 |
| Fax |
|
| Email |
drgraghu-yoga@maher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Voleti venkata sucharita |
| Designation |
Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department Faculty of Yoga Science and Therapy Division 3rd floor Room No 303 No 12 Vembuliamman Koil Street West K K Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7671959343 |
| Fax |
|
| Email |
venucherry2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy of Higher Education and Research (Deemed to be University) No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai - 600078 |
|
|
Primary Sponsor
|
| Name |
Voleti venkata suchairta |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No 12 Vembuliamman Koil Street West K K Nagar Chennai |
| 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 G Raghuram |
Meenakshi Academy of Higher Education and Research |
Department: Faculty of Yoga Science and Therapy
Division: 3rd Floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai
Chennai
TAMIL NADU |
9840691849
drgraghu-yoga@maher.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Will be in active rest |
| Intervention |
Yoga |
Asana, pranayama, meditation, mudras, chanting would be used.
Frequency : 5 times a Week
Total Duration : 6 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. The age limit of subjects would be confined to 18 to 25 years only.
2. Willingness to participate in the study and sign the written consent form.
3. Those diagnosed with PCOS based on the reports.
4. The participants should not have any disability. |
|
| ExclusionCriteria |
| Details |
1. The participants who have hormonal imbalances and thyroid issues would not be
taken into consideration.
2. The participants who are with neuro-endocrine issues, who are dependent on insulin,
and who are on hormonal pills would not be taken into consideration.
3. Certain factors like lifestyle, food habits, body alignment and personal way of life are
not to be taken into consideration.
4. Factors like climate conditions, environmental and socio-economic status are not to be
taken into consideration.
5. The day-to-day routines would not be controlled for this study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. USG
2. Testosterone
3. Lipid profile
|
Frequency: 5 days a week
Duration: 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Anthropometric
2. Psychological Variables (Depression, Anxiety, Stress Questionnaire) |
Frequency: 5 days a week
Duration: 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/11/2024 |
| 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="1"
Months="6"
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 study would be conducted for the partial fulfilment off the PhD study at Meenakshi Academy of Higher Education and Research (Deemed to be University), Chennai
This study explores yoga’s potential as a complementary therapy for college students with
PCOS. Comparing yoga intervention with a controlled group, it analyses effects on hormonal
imbalance, body composition, and mental well-being. The research aims to integrate yoga
into PCOS management plans for improved health and well-being in young women. This study delves into the effectiveness of yoga as a complementary therapy for college
students grappling with Poly Cystic Ovarian Syndrome (PCOS). Experimental group
of Yogis will be immersed in daily practice of Surya Namaskar, Asanas, Mudras, Meditation
and Pranayama for 6 months, the Controlled group will be engaging in active rest over the same
period. Aim is to uncover the impact of yoga on various aspects of life for these young women,
from hormonal imbalance and body composition to menstrual regularity and mental well
being. |