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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  
ICMR 
 
Primary Sponsor  
Name  ICMR  
Address  Ansari Nagar, New Delhi, 110029  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: PCOS ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Continuous Lifestyle ArmDiet, physical activity, sleep, stress management, social connectedness, avoidance of drug abuse. Total duration 12 months and total 13 visits
2Intervention ArmLifestyle--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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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