| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| 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.
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