| CTRI Number |
CTRI/2025/12/098684 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying whether adding yoga to usual treatment can improve urinary symptoms and quality of life in older men with prostate enlargement |
|
Scientific Title of Study
|
Effectiveness of Yoga as an Adjuvant Therapy on Lower Urinary Tract Symptoms and Quality of Life among Older Adults with Benign Prostatic Hyperplasia: A 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 |
Arun Sankar M |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Geriatric Medicine ,AIIMS Rishikesh, Uttarakhand- 249203
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7868916292 |
| Fax |
|
| Email |
asankar0114@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Pathania |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Geriatric Medicine ,AIIMS Rishikesh, Uttarakhand- 249203
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Sankar M |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Geriatric Medicine ,AIIMS Rishikesh, Uttarakhand- 249203
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7868916292 |
| Fax |
|
| Email |
asankar0114@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , Virbhadra Road, Rishikesh
Uttarakhand- 249203, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arun Sankar M |
All India Institute of Medical Sciences -Geriatric OPD and Urology OPD |
Department of Geriatric Medicine , AIIMS Rishikesh, UK
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
Dehradun
UTTARANCHAL |
07868916292
asankar0114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Medication (TABLET TAMSULOSIN 0.4 MG OD) |
Participants in the control group will receive only the usual prescribed medication for benign prostatic hyperplasia , without yoga or any additional lifestyle intervention.
Duration: 90 days (same as intervention arm).
Mode of delivery: As prescribed by treating physician; routine follow-up as per protocol. |
| Intervention |
Yoga + standard medication (TABLET TAMSULOSIN 0.4MG PO OD) |
Participants in the intervention group will receive a standardized yoga module designed for men with lower urinary tract symptoms. The module includes breathing exercises , loosening practices , asanas focused on pelvic floor and core strengthening , and relaxation/meditation .
Duration & frequency: 30 minutes per session, 5 days per week, for 90 days.
Mode of delivery: Supervised sessions by a qualified yoga instructor, with home practice encouraged on non-supervised days.
Co-intervention: All participants will continue their standard BPH medication as prescribed by the treating clinician. No other additional therapies will be added. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients of age above 60 years
2. Patients with LUTS with Mild and Moderate scores as per International Prostate Symptom Score) IPSS.
3. Patients having Robust and Pre-frail scores as per Fried Frailty Scale
4. Patients must have a confirmed diagnosis of BPH, based on clinical evaluation, medical history, and/or diagnostic tests such as digital rectal examination, uroflowmetry, prostate-specific antigen levels, and ultrasonography.
5. Patients must be physically capable of participating in yoga sessions, including the ability to perform basic physical movements and tolerate moderate physical exertion
6. Patients willing to participate in the study by attending 75 percent of yoga sessions and comply with study assessments
7. Not practising any structured yoga for last 6 months
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe medical conditions that may significantly impact their ability to participate in the yoga intervention such as uncontrolled cardiovascular disease, severe musculoskeletal disorders
2. Patients who have undergone recent surgical procedures related to BPH management, such as transurethral resection of the prostate prostatectomy
3. Patients with active urinary tract infections may influence urinary symptoms or require immediate medical treatment should be excluded until the infection is resolved
4. Patients with neurological illness like spinal cord injury, progressive neurodegenerative disease
5. Patients with cognitive impairment may impair their ability to understand and comply with the study
6. Patients with vesical calculi, recurrent UTI, obstructive uropathy, high post void residual urine volume, raised serum PSA.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of three months to see change in IPSS |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in quality of life after three months of yoga therapy
2.Assess changes in LUTS severity following a structured yoga intervention.
3.Evaluate the impact of yoga on urinary flow rates & other objective measures of urinary function.
4.Examine the effects of yoga on quality of life, including physical, psychological, & social well-being.
5.Measure the improvement in balance, lower extremity function & functional quality of life after yoga intervention using SPPB.
6.Explore participant adherence to the yoga intervention & potential predictors of treatment response.
7.To measure the change in size of prostate after yoga therapy
8.To assess the levels of Serum Dihydrotestosterone after Yoga therapy. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/12/2025 |
| 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="0"
Months="3"
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
|
This study is a randomized controlled trial evaluating the effectiveness of yoga as an adjuvant therapy in older adults with Benign Prostatic Hyperplasia (BPH). The study aims to assess the impact of yoga on Lower Urinary Tract Symptoms (LUTS) and Quality of Life (QoL).
Participants aged 60 years and above, diagnosed with BPH and mild-to-moderate LUTS, will be randomly allocated into two groups using computer-generated randomization (1:1 ratio). The intervention group will receive standard medication along with yoga therapy, while the control group will receive only standard medication. Yoga sessions will be conducted for 90 days, and adherence will be monitored.
Primary outcomes include changes in IPSS scores and QoL measures, while secondary outcomes will assess adherence and any adverse events.
This study follows ethical guidelines, and informed consent will be obtained from all participants. |