| CTRI Number |
CTRI/2025/04/084920 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga-Diet therapy on weight management, menstrual, hormonal parameters and Quality of Life in Women with ovary cyst: A Randomized Controlled Trial |
|
Scientific Title of Study
|
A randomized controlled trial to assess the impact of yoga-diet synergy on vital parameters and quality of life among women with polycystic ovary syndrome at tertiary care hospital, Mangalagiri |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Kaleeswari |
| Designation |
Nursing Tutor |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
College of Nursing
All India Institute of Medical Sciences
Mangalagiri
All India Institute of Medical Sciences
Mangalagiri
Guntur District
Andrapradesh 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7358200728 |
| Fax |
|
| Email |
kalisaiims@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Rajalakshmi |
| Designation |
Principal and Guide |
| Affiliation |
Bharath institute of Higher Education and Research |
| Address |
Sri Lakshmi Narayana College of Nursing
Agaram village
osudu taluk
Puducherry
173 Agharam Road
Selaiyur
Chennai 600073
Pondicherry
PONDICHERRY
605502
India |
| Phone |
7010789316 |
| Fax |
|
| Email |
rajalakshmibaskaran2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila |
| Designation |
Head of the OBG Department and Co Guide |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Department of Obstetric and Gynecology
Third floor OPD Block
AIIMS
Mangalagiri
All India Institute of Medical Sciences
Mangalagiri
Guntur District
Andrapradesh 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9843776367 |
| Fax |
|
| Email |
sharmila.obg@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Mangalagiri, Andrapradesh-522503 |
|
|
Primary Sponsor
|
| Name |
G KALEESWARI |
| Address |
AIIMS, MANGALAGIRI, ANDRA PRADESH-522503 |
| 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 Sharmila |
All India Institute of Medical Sciences |
ROOM NO.301 TO 310, DEPARTMENT OF OBG, AIIMS, MANGALAGIRI
Guntur
ANDHRA PRADESH |
9843776367
sharmila.obg@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine conventional treatment for PCOS as prescribed by Doctor |
Routine medications, advice on diet and exercise |
| Intervention |
Yoga-Diet Synergy along with routine conventional treatment |
Yoga includes Asanas, Pranayama, deep relaxation and diet include low calorie diet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women who are
Newly diagnosed with PCOS
Age between 18 to 35 Years
Both married and unmarried women
Overweight and Obese (BMI more than 23)
Not on any weight management or Yoga therapies other than allopathy medicine.
|
|
| ExclusionCriteria |
| Details |
Women who are
Pregnant
Lactating woman
Any other illness including reproductive illness which alters reproductive hormones and menstrual cycle and affecting ovulation or cause hyperandrogenemia
hyperprolactenaemia
androgen secreting ovarian or adrenal tumors hypothyroidism
cushings syndrome
acromegaly based on history recorded by obstrician
Placed Intra uterine devices
Physical limitations to perform yoga
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
BMI
WHR
Menstrual parameters
Quality of life |
Baseline
at 4 weeks
at 8 weeks
at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hirsutism Ferrimen gallwey score
Hormonal profile such as Testosterone
FSH
LH
FSH LH Ratio
Prolactin |
after 108th day of pretest |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
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)
|
05/05/2025 |
| 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 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
|
The study is a randomized, single blind, parallel group trail to assess the impact of Yoga diet synergy among women with Poly cystic ovary syndrome. The intervention is planned for 12 weeks for study group participants along with conventional treatment, whereas control group will receive only conventional treatment without structured yoga diet module. The primary outcome measures BMI, WHR, Menstrual parameters like duration, frequency of menstruation and dysmenorrhea, Quality of life of women which will be assessed after 36th day, 72nd day and 108th day of pretest. The secondary outcome will be measuring Hirsutism , Hormonal profile such as Testosterone, FSH, LH ,FSH LH ratio, prolactin which will be measured after 108 days of pretest. In addition to this clinical variables such as blood sugar, BP, USG Findings will be assessed. |