FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101093 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 11/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Exploratory Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on the Effect of Yoga in Men Suffering from Premature Ejaculation 
Scientific Title of Study   Development, Validation and Feasibility Testing of Yoga Module for Premature Ejaculation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deven Lodha 
Designation  MD SCHOLAR SWASTHAVRITTA 
Affiliation  Dr. D.Y. Patil College of Ayurved and Research Centre 
Address  OPD no.7, Swasthvritta evam yoga department, Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  8087290610  
Fax    
Email  devenlodha679@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Urmila Shirke 
Designation  HOD Professor Swasthvritaa Evam Yoga Department 
Affiliation  Dr. D.Y. Patil College of Ayurved and Research Centre, Pune 
Address  OPD no. 7, Swasthavritta Evam Yoga Department, Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9850769938  
Fax    
Email  drujshirke@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deven Lodha 
Designation  MD SCHOLAR SWASTHAVRITTA 
Affiliation  Dr. D.Y. Patil College of Ayurved and Research Centre 
Address  OPD no 7, Swasthavritta Evam Yoga Department, Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune


MAHARASHTRA
411018
India 
Phone  8087290610  
Fax    
Email  devenlodha679@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y. Patil College of Ayurved and Research Centre, Pimpri, Pune.  
 
Primary Sponsor  
Name  Deven Lodha 
Address  OPD no 7, Swasthavritaa evam Yoga Department, Dr. D.Y. Patil College of Ayurved and Research Centre, Pimpri, Pune 411018 
Type of Sponsor  Other [Self] 
 
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 Deven Lodha  Dr. D.Y. Patil College of Ayurved and Research Centre  OPD no 7, Swasthavritta evam Yoga Department, Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA 
8087290610

devenlodha679@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  adult married males above 24yrs of age, having an intra-vaginal ejaculation time of 1min or less 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Male participants aged 21 to 50 years
Married or in a stable heterosexual relationship
Diagnosed with Premature Ejaculation
IELT less than 2 minutes
Persistent symptoms for 6 months or more
Not practicing structured Yoga for sexual health in the last 3 months
 
 
ExclusionCriteria 
Details  Erectile dysfunction
Major psychiatric illness or on psychotropic drugs
Organic causes of PE like prostatitis, genital infection or any pelvic surgery
Severe systemic illness like uncontrolled diabetes, hypertension or thyroid disorder
Use of drugs affecting ejaculation like SSRIs, tramadol, PDE-5 inhibitors, topical anesthetics
Alcohol or substance abuse
Severe musculoskeletal, neurological or spinal disorders contraindicating Yoga 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a validated and feasible yoga module on premature ejaculation will be developed  yoga module will be developed and sent for validation from experts, for the feasibility testing, at day 1 pt will be assessed for premature ejaculation and any other illness, at day 10 again pt will be assessed for the feasibility of the yoga module and at the end of 30 days last feasibility testing will be done 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/02/2026 
Date of Study Completion (India) 21/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Premature ejaculation is one of the most common male sexual disorders and has a significant impact on quality of life, marital harmony, and psychological well-being. Existing pharmacological treatment options have limitations, including adverse effects, dependency, and variable long-term adherence. Yoga has been reported to improve autonomic balance, stress regulation, pelvic floor function, and sexual health; however, a standardized yoga module specifically designed for premature ejaculation has been lacking.

This study was conducted to develop, validate, and assess the feasibility of a structured yoga module for the management of premature ejaculation. The yoga module was developed through a comprehensive review of classical yogic texts and contemporary scientific literature and was subsequently validated by a panel of 20 experts. Following expert validation, a single-arm interventional feasibility study was carried out among 10 male participants diagnosed with premature ejaculation. Participants practiced the validated yoga module under supervision for a period of one month.

The study assessed the feasibility, acceptability, adherence, retention, and safety of the intervention, along with preliminary clinical outcomes related to premature ejaculation. Outcome measures included the Premature Ejaculation Diagnostic Tool (PEDT), Intravaginal Ejaculatory Latency Time (IELT), Sexual Satisfaction Visual Analogue Scale (VAS), and the Depression Anxiety Stress Scale (DASS-21). The findings support the feasibility and acceptability of the developed yoga module and provide preliminary evidence to inform future larger-scale clinical trials.


 
Close