| CTRI Number |
CTRI/2025/07/089943 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving PCOS Health:The Role of Yoga Alongside Standard Treatment |
|
Scientific Title of Study
|
Effect of Adjunctive Yoga with Standard Therapy on Biochemical Markers and Quality of Life in Women with PCOS: 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 KOMAL KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Obstretics and Gynaecology department,AIIMS Gorakhpur, Medical College Building, Kunraghat, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9430177437 |
| Fax |
|
| Email |
komal.nikk1012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARADHANA SINGH |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Obstretics and Gynaecology,AIIMS Gorakhpur, Medical College Building, Kunraghat, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9415316655 |
| Fax |
|
| Email |
Aradhanamdobg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KOMAL KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Obstretics and Gynaecology,AIIMS Gorakhpur, Medical College Building, Kunraghat, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9430177437 |
| Fax |
|
| Email |
komal.nikk1012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims Gorakhpur,Kunraghat,Gorakhpur,273008,Uttar Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Dr Komal Kumari |
| Address |
AIIMS Gorakhpur, Medical College Building, Kunraghat, Gorakhpur, Uttar Pradesh,273008,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 |
| Dr Komal Kumari |
Gynaecology OPD of AIIMS Gorakhpur |
Aiims Gorakhpur,Kunraghat
Gorakhpur
UTTAR PRADESH |
9430177437
komal.nikk1012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC,Aiims Gorakhpur |
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 |
Standard treatment |
Standard treatment (as per institutional PCOS protocol).
It typically includes lifestyle modifications like diet and exercise to improve insulin sensitivity
and reduce weight. Hormonal contraceptives (e.g.,combined oral pills) are used to regulate
menstrual cycles and reduce androgen levels.. Anti-androgens may be added for severe acne or
hirsutism, and fertility treatments like clomiphene or letrozole are used when pregnancy is
desired. Treatment is individualized based on symptoms. |
| Intervention |
Yoga |
Structured Yoga program Through Online Yoga Sessions (60 minutes/
session, 4 sessions/week for 12 weeks)
total duration=18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women between the ages of 18 and 45 years who are meeting the inclusion criteria,
according to Rotterdam guidelines
Informed and consenting women |
|
| ExclusionCriteria |
| Details |
1.Current use of hormonal therapy or alternative therapy such as Metformin for insulin
resistance
2. Known endocrine disorders(thyroid,adrenal)
3. Participants with chronic conditions such as hypertension, diabetes, renal disorders, or
malignancies will be excluded from the study.
4. Psychiatric illness or pregnancy
5. Loss to follow up participants
6. Not following the prescribed protocol of standard treatment and intervention |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the effect of standard treatment alone versus standard treatment with adjunct yoga
on biochemical parameters in women with PCOS.
2. To evaluate the impact of adjunct yoga on the quality of life in PCOS patient. |
At baseline and after 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
31/07/2025 |
| 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="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
|
Effect of Adjunctive Yoga with Standard Therapy on Biochemical Markers and Quality of Life in Women with PCOS: A Randomized Controlled Trial Objectives- 1.To compare the effect of standard treatment alone versus standard treatment with adjunct yoga on biochemical parameters in women with PCOS. 2. To evaluate the impact of adjunct yoga on the quality of life in PCOS patient.
|