| CTRI Number |
CTRI/2026/01/100658 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Adjuvant Yoga Therapy for PCOS: A RCT |
|
Scientific Title of Study
|
Effect Of Adjuvant Yoga Therapy on Bio-Psycho-Social Parameters in Patients of PCOS: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshna W D |
| Designation |
PhD Research scholar |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
1st floor, I block, School of Yoga Therapy, Institute of Salutogenesis and Complementary Medicine, Sri Balaji Vidyapeeth, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6382732936 |
| Fax |
|
| Email |
wdroshna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananda Balayogi Bhavanani |
| Designation |
Director and Professor |
| Affiliation |
Institute of Salutogenesis and Complimentary Medicine |
| Address |
1st floor, I block, Institute of Salutogenesis and Complementary Medicine, Sri Balaji Vidyapeeth, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9842311433 |
| Fax |
|
| Email |
yognat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananda Balayogi Bhavanani |
| Designation |
Director and Professor |
| Affiliation |
Institute of Salutogenesis and Complimentary Medicine |
| Address |
1st floor, I block, Institute of Salutogenesis and Complementary Medicine, Sri Balaji Vidyapeeth, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9842311433 |
| Fax |
|
| Email |
yognat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute of Sri Balaji Vidyapeeth (Deemed to be a university), Pillaiyarkuppam, Pondicherry, 607403 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Ananda Balayogi Bhavanani |
Institute of Salutogenesis and Complimentary Medicine |
1st floor, I block, School of Yoga Therapy, Institute of Salutogenesis and Complementary Medicine, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry
Pondicherry
PONDICHERRY |
9842311433
wdroshna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee MGMCRI |
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 |
Standard Medical Management |
| Intervention |
Yoga Therapy |
Yoga Therapy protocol will be given to subjects in the experimental group along with standard medical management. The participants will receive guided session twice a week Participants would be motivated to practice at home every day,what is taught each week in the
guided session. At the end of 6 months study period, post-data will be collected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed with PCOS using Rotterdam criteria and Criteria of PCOS in adolescents of PCOS society. Patients with ovulatory problems. |
|
| ExclusionCriteria |
| Details |
Other gynaecological issues such as uterine bleeding, uterine fibroids, and tumours.
Patients of Infertility unrelated to PCOS.
Individuals undergoing other therapies.
Patients who are unwilling or physically unable to participate in yoga practices. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
the effect of adjuvant yoga therapy on enhancement of
quality of life among patients with PCOS. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The effect of AYT on anthropometric parameters in PCOS (body weight,body mass index (BMI), Waist circumference).
The impact of AYT on physiological parameters (heart rate and blood pressure)
The psychological effects of AYT in PCOS (Sense of Coherence, Pittsburgh Sleep quality index (PSQI), Polycystic Ovary Syndrome Questionnaire (PCOSQ),Social Wellness Assessment).
The influence of AYT on clinical parameters (menstrual regularity,ovulation seen by serial scan, Skin manifestation).
The effect of AYT on biochemical parameters (Oral Glucose Tolerance Test (OGTT-75mg), Lipid Profile Test, Total Serum Testosterone levels, HOMA IR (insulin resistance), and insulin signalling pathways. |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
03/02/2026 |
| 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="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
|
Introduction:Yoga Therapy has proved to be a scientific, non-surgical, feasible, cost-effective, and efficient method that can manage and reduce PCOS. Yoga therapy has a multi-dimensional approach to this condition. Among complementary and alternative therapies, yoga has its unique integrated approach to dealing with PCOS. Aim:
To study the effect of adjuvant yoga therapy on Bio-Psycho-Social parameters in patients of PCOS |