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CTRI Number  CTRI/2025/09/094401 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Electrical Muscle Stimulation: A New Approach to Managing PCOS Health Challenges 
Scientific Title of Study   Impact of Electrical Muscle Stimulation on Metabolic, Somatic, and Psychosocial Health in Polycystic Ovary Syndrome Patients: A Randomized Control 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  Divya Goyal  
Designation  Research Scholar  
Affiliation  Department of physiotherapy , School of healthcare and allied sciences ,GD Goenka University  
Address  Room No. B-421, fourth floor , GD Goenka Educational City, Sohna - Gurgaon Rd, Sohna, Sohna Rural, Haryana

Gurgaon
HARYANA
122102
India 
Phone  7986875255  
Fax    
Email  divya.goyal@gdgu.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Tabish Fahim 
Designation  Associate Professor  
Affiliation  Department of physiotherapy , School of healthcare and allied sciences ,GD Goenka University  
Address  Room No. B-421, fourth floor , GD Goenka Educational City, Sohna - Gurgaon Rd, Sohna, Sohna Rural, Haryana

Gurgaon
HARYANA
122102
India 
Phone  9718481337  
Fax    
Email  tabish.fahim@gdgu.org  
 
Details of Contact Person
Public Query  
Name  Divya Goyal  
Designation  Research Scholar  
Affiliation  Department of physiotherapy , School of healthcare and allied sciences ,GD Goenka University  
Address  Room No. B-421, fourth floor , GD Goenka Educational City, Sohna - Gurgaon Rd, Sohna, Sohna Rural, Haryana

Gurgaon
HARYANA
122102
India 
Phone  7986875255  
Fax    
Email  divya.goyal@gdgu.org  
 
Source of Monetary or Material Support  
Department of Physiotherapy School of Allied and healthcare Sciences GD Goenka University Gate No 3 G D Goenka Education City Sohna Gurgaon Rd Sohna Rural Haryana India 122103 
 
Primary Sponsor  
Name  NIL 
Address  NIL  
Type of Sponsor  Other [NIL ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Sapra   GD Goenka University  Room no B421 fourth floor Department of Physiotherapy school of healthcare and allied sciences GD Goenka University Sohna Gurgaon Rd Sohna Rural Haryana 122103
Gurgaon
HARYANA 		 9717719124

Priyanka_baweja@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Wave Women Empowerment Trust   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL GROUP   Participants shall be encouraged to carry therapeutic regime and medication or advice suggested by the medical expert Patient education regarding PCOS control shall be provided 
Intervention  EMS INTERVENTIONAL GROUP   Multi-channel 8 channels electrical stimulator will be used to deliver Russian current of 2500 Hz of motor level intensity with 10 seconds of stimulation followed by 50 second rest. Muscles of lower limb gluteal hamstrings quadriceps Calf and abdomen will be stimulated simultaneously for 30 minutes using standard clinical protocol Crowe and Caulfield 2012 Subject shall receive 3 sessions per week for the period of 3 months 12 weeks Apart from EMS Protocol participants will be encouraged to carry therapeutic regime and medication or advice suggested by the medical expert 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Medically diagnosed and according to Rotterdam criteria (at least two of the following oligo/anovulation, clinical and/or biochemical signs of hyperandrogenism, polycystic ovaries)BMI more than 24 kg/m² (Sam S. Obesity and Polycystic Ovary Syndrome. Obes Manag. 2007 Apr;3(2):69-73. doi: 10.1089/obe.2007.0019. PMID: 20436797; PMCID:PMC2861983) Willing to provide informed consent and comply with study protocol. 
 
ExclusionCriteria 
Details  Use of hormonal medications like oral contraceptives within the last 3 months Pregnant or planning to become pregnant within the study period Any neurological disorders like multiple sclerosis amyotrophic lateral sclerosis Guillain Barre syndrome etc Any systemic disease like liver dysfunction IBD Kidney failure etc Any congenital disorders like Turner Syndrome Congenital Adrenal Hyperplasia Marfan syndrome History of Cancer Diagnosed with other endocrine disorders like thyroid dysfunction Cushing syndrome etc History of any cardiovascular diseases like uncontrolled hypertension unstable angina etc Participation in another clinical trial at present and within the last six months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Insulin Resistance Menstrual health Glucose metabolism Plasma Glucose level Hyperandrogenism quality of life   base line 12 weeks and follow up 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
BMI , Body composition analysis , hip to waist ratio   base line 12 weeks and follow up 3 months  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   16/10/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 16-10-2025 and end date provided 31-03-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Polycystic Ovary Syndrome PCOS is a common endocrine disorder in women of reproductive age associated with metabolic, somatic and psychological complications. Current treatments rely on lifestyle changes and medications but often face adherence challenges. Electrical Muscle Stimulation EMS is a non invasive method that mimics exercise by inducing muscle contractions and may improve insulin sensitivity, metabolic health, body composition and quality of life. This randomized controlled trial aims to evaluate the effects of a 12 week EMS program on metabolic parameters glucose, insulin resistance, lipid profile, blood pressure, testosterone, somatic outcomes body weight, BMI, waist to hip ratio, body composition and psychosocial health quality of life, mood, anxiety and menstrual well being in women with PCOS. The study seeks to provide evidence for EMS as a novel adjunct therapy for improving health outcomes and quality of life in PCOS patients. 
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