| CTRI Number |
CTRI/2025/07/090805 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Investigating the Effectiveness of Continuous vs Stepwise Lifestyle Change Strategies in PCOS for 12 months: A Multicentric Randomized Study |
|
Scientific Title of Study
|
Evaluation of Comparative efficacy of Continuous vs. Stepwise Implementation Approaches for 12 -Month Lifestyle Medicine Interventions among Polycystic Ovarian Syndrome Patients: A Multicentric 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 |
Raj Kumar Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 2004, Teaching block, Department of Physiology, All India Institute of Medical Sciences, New Delhi- 110029
South DELHI 110029 India |
| Phone |
01126546461 |
| Fax |
|
| Email |
raj3kr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Charushila Rukadikar |
| Designation |
Asstt Professor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Dept of Physiology
All India Institute of Medical Sciences
Gorakhpur
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
9689865748 |
| Fax |
|
| Email |
charuruks11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Charushila Rukadikar |
| Designation |
Asstt Professor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Dept of Physiology
All India Institute of Medical Sciences
Gorakhpur
UTTAR PRADESH 273008 India |
| Phone |
9689865748 |
| Fax |
|
| Email |
charuruks11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ansari Nagar, New Delhi, 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradip Barde |
All India Institute of Medical Sciences |
Room No. 1003, 1st Floor, Academic Block, Dept of Physiology, AIIMS, Rajkot Rajkot GUJARAT |
9021416946
bardepb@gmail.com |
| Dr Prathamesh Haridas Kamble |
All India Institute of Medical Sciences |
Room No. 120, 1st Floor, Dept of Physiology, Medical College Building, AIIMS, Nagpur Nagpur MAHARASHTRA |
9689865748
charuruks11@gmail.com |
| Dr Raj Kumar Yadav |
All India Institute of Medical Sciences |
Room No 2004, 2nd Floor, Teaching Block, Dept of Physiology,AIIMS, New Delhi, 110029 South DELHI |
01126546461
raj3kr@gmail.com |
| Dr Varun Malhotra |
All India institute of Medical sciences |
Room No. 13, Dept of Physiology, Medical College Building, B & C Wing, AIIMS, Bhopal
Bhopal Bhopal MADHYA PRADESH |
8287215376
varun.physiology@aiimsbhopal.edu.in |
| Dr Charushila Rukadikar |
All India Institute of Medical Sciences (AIIMS) |
Dept of Physiology, 1st Floor, MNC Building, AIIMS, Gorakhpur Gorakhpur UTTAR PRADESH |
9689865748
charuruks11@gmail.com |
| Dr Milind Abhimanyu Nisargandha |
Sundarlal Patwa Government Medical College |
Dept of Physiology, 2nd Floor, Academic Block, Sundarlal Patwa Government Medical College Mandsaur MADHYA PRADESH |
9834087840
manisargandha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AlIMS, New Delhi |
Submittted/Under Review |
| Institute Human Ethics Committee, AIIMS, Gorakhpur |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Human Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: PCOS , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Continuous Lifestyle Arm | Diet, physical activity, sleep, stress management, social connectedness, avoidance of drug abuse. Total duration 12 months and total 13 visits | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: NA, Ritucarya: NA, Acara Rasayana:NA, Other:2-1-2-1 step wise approach. Diet & physical activity. next sleep, next, stress management & social connectedness, finally, avoidance of drug abuse. Total duration 12 months. Total 13 visits, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Participants who will provide informed consent& available for follow-up assessments indicating their willingness to participate in the research study, including undergoing randomization to either the continuous or stepwise implementation group.
2. Subjects having diagnosis of PCOS based on modified Rotterdam criteria
3. Patients taking following standard of care treatment for PCOS
a. Hormonal Treatment (Oral Contraceptive)
30 mcg Ethinyl Estradiol + 150 mcg Levonorgestrel, Once daily (for 21 days followed by 7-day break)
b. Insulin-Sensitizing Agent
Metformin, 1000 mg, Twice daily
Myoinositol, 1000 mg, Once daily |
|
| ExclusionCriteria |
| Details |
1.Participants who are currently pregnant & breastfeeding, as breastfeeding can also impact hormonal levels and may interfere with the interventions or assessments.
2.Participants with severe medical conditions which include uncontrolled diabetes, , severe mental health disorders.
3.Participants with hyperprolactinemia and thyroid abnormality
4.Participants taking medicines as antipsychotics drugs, antidepressants drugs.
5.Presence of other causes of androgen excess and anovulatory infertility, such as: Congenital adrenal hyperplasia, Cushing syndrome, Androgen-secreting tumors
6.History of bariatric surgery or planning to undergo other weight loss strategies during the study period.
7.Women with lower limb pathology or any condition that precludes participation in physical activity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of continuous Vs stepwise lifestyle medicine interventions over 12 months in terms of improving PCOS
Assessments: Ovarian volume, Menstrual cycle history, Polycystic Ovarian morphology, hormonal and biochemical assay, dietary assessment etc. |
Baseline, every 15 days for first 2 months, followed by every month till 12 months |
|
|
Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="612" Sample Size from India="612"
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)
|
01/09/2025 |
| 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="3" 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 commonly observed endocrine disease in women of reproductive age. Disrupted hormonal balance and metabolic disturbances distinguish it. Although Lifestyle Medicine (LM) therapies are commonly advised for the treatment of PCOS, there is a scarcity of research that compares the outcomes between continuous and stepwise implementation approaches. LM is a medical specialty that uses therapeutic LM as a primary modality to treat chronic conditions. Applying the six pillars of LM, viz., whole-food, plant-predominant eating pattern, physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connections, provides effective prevention for these conditions. The originality of this study is to assess the effectiveness and practicality of continuous implementation compared to stepwise implementation of LM therapies in enhancing health outcomes and quality of life among patients with PCOS. Addressing all six domains of LM at the initial stage of treatment can present challenges. It could result in a less positive reaction to the treatment. Our hypothesis suggests that implementing targeted domain treatment in a 2-1-2-1 format could potentially enhance the efficacy of the treatment. The study aims to enlist individuals with PCOS from various centers and allocate them randomly to either the continuous or stepwise implementation groups. Here, a randomized controller trial for 12 months will assess hormonal profiles, polycystic ovarian morphology, menstrual regularity, metabolic parameters, and physical fitness, stress, circadian rhythm,sleep, diet, addiction, social connections, and quality of life among PCOS patients. |