| CTRI Number |
CTRI/2025/07/090623 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for PCOS |
|
Scientific Title of Study
|
Effect of Shakti Bandha Asana on Continuous Glucose Monitoring Among Patients with Polycystic Ovarian Syndrome(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 |
A Keerthana |
| Designation |
UG Student |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga,Kamarajar Nagar, Chengalpattu.
Kancheepuram
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7550183112 |
| Fax |
|
| Email |
keerthanaa31216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri A |
| Designation |
Head of the Department (i/c) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga,Kamarajar Nagar, Chengalpattu.
Kancheepuram
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Keerthana |
| Designation |
UG Student |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga,Kamarajar Nagar, Chengalpattu.
Kancheepuram
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7550183112 |
| Fax |
|
| Email |
keerthanaa31216@gmail.com |
|
|
Source of Monetary or Material Support
|
| 184/4, First Floor, Room No 1, Department of Yoga, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu, 603001 |
|
|
Primary Sponsor
|
| Name |
Directorate of Indian Medicine and Homoeopathy |
| Address |
Arumbakkam, Near Anna Arch, Chennai-600106 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gayathri |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,First Floor,Room No: 1, Department of Yoga, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga,Kamarajar Nagar, Chengalpattu.
Kancheepuram, 603001
Kancheepuram
TAMIL NADU |
8124634017
gayathriannamalai93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shakthi Bandha Asana |
The study group participants will receive a day of orientation program before the trial. Subjects will be advised to follow the Shakti Bandha Asana series asanas (Rajju Karshanasana, Gatyatmak Meru Vakrasana, Chakki Chalanasana, Nauka Sanchalanasana, Kashtha Takshanasana, Namaskar asana, Vayu Nish asana, Kauva Chalasana, Udarakarshanasana) for 30 minutes per session, two times a day for 14 days, preferably 7 am to 8 am before breakfast and 4 to 5 pm under direct supervision |
| Comparator Agent |
Waitlist Control Group |
The subjects in the wait list control group will be advised to concentrate on their breathing in the sitting position for 30 minutes per session, two times a day for 14 days preferably 7 am to 8 am before breakfast and 4 to 5 pm under direct supervision. After the post-assessment control group subjects will also receive Shakti Bandha Asana intervention |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Female |
| Details |
At least two-thirds of the features listed in the Rotterdam criteria for PCOS,
Oligomenorrhea or Amenorrhea,
Clinical Hyperandrogenism (Ferriman–Gallwey scale). |
|
| ExclusionCriteria |
| Details |
Patients reported adverse events in patch test
Hormonal treatment or used oral contraceptives
Thyroid abnormalities
A prior experience of yoga |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time in range (TIR)
HbA1c |
Assessment will be evaluated the day before and the day after the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Cholesterol
HDL(High Density Lipoprotein)
LDL(Low Density Lipoprotein)
CRP(C Reactive Protein) |
Assessment will be evaluated the day before and the day after the intervention. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/08/2025 |
| 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="0"
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
|
Polycystic Ovarian Syndrome (PCOS) is a common endocrine disorder in reproductive-age women, marked by irregular menstrual cycles, hyperandrogenism, and polycystic ovaries. It is associated with metabolic dysfunction, particularly insulin resistance, hyperinsulinemia, and impaired glucose metabolism. Insulin resistance is central to PCOS pathology, leading to increased androgen production, worsening symptoms like hirsutism, acne, and anovulation. Traditional blood glucose monitoring, including fasting blood glucose (FBG) and hemoglobin A1c (HbA1c), offers limited insights, giving only a snapshot of glucose levels. In PCOS, glucose levels can fluctuate due to hormonal imbalances, stress, and diet. Continuous Glucose Monitoring (CGM) allows real-time glucose tracking, providing a thorough assessment of glycemic patterns and insulin sensitivity. CGM measures Time in Range (TIR), glycemic variability (GV), and mean glucose levels, enabling detailed evaluation of metabolic status. It is effective for assessing lifestyle interventions on glucose regulation in PCOS patients. Yoga is recognized for its benefits on metabolic and hormonal disorders, including PCOS. Shakti Bandha Asanas (Energy Locking Postures) stimulate endocrine glands, improve circulation, and enhance metabolic function. These asanas promote hormonal balance and improve insulin sensitivity. The gentle stretching, controlled breathing, and relaxation techniques in these postures positively influence glucose metabolism and overall metabolic health in PCOS patients. This study aims to evaluate their effects on real-time glucose fluctuations in PCOS patients using CGM. This randomized controlled trial (RCT) investigates whether Shakti Bandha Asanas can improve glycemic control in PCOS patients. CGM data is expected to show increased TIR and reduced blood glucose fluctuations, indicating better metabolic control. Secondary benefits may include improved menstrual regularity, reduced insulin resistance, and enhanced stress management. PCOS is a multifaceted disorder requiring holistic management.
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