| CTRI Number |
CTRI/2026/02/103758 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the benefits of selected yoga exercises and Kegel exercises in prostate enlargement |
|
Scientific Title of Study
|
A Comparative clinical trial to assess the effect of selected yoga techniques and kegel exercises in benign prostatic hyperplasia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishanth Naik G |
| Designation |
PG Scholar, Department of Swasthavritta |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Second year PG Scholar,Department of Swasthavritta, Government Ayurveda College and Hospital, Dhanwantari Nagar, Puthiyakavu,Tripunithura, Ernakulam,Kerala, 682301
Ernakulam
KERALA
682301
India |
| Phone |
7907919906 |
| Fax |
|
| Email |
naiknishanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuraj S |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Associate Professor,Department of Swasthavritta,Government Ayurveda College and Hospital, Dhanwantari Nagar, Puthiyakavu,Tripunithura, Ernakulam,Kerala, 682301
Ernakulam
KERALA
682301
India |
| Phone |
9447102737 |
| Fax |
|
| Email |
drvinurajs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinuraj S |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Associate Professor,Department of Swasthavritta,Government Ayurveda College and Hospital, Dhanwantari Nagar, Puthiyakavu,Tripunithura, Ernakulam,Kerala, 682301
KERALA
682301
India |
| Phone |
9447102737 |
| Fax |
|
| Email |
drvinurajs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital, Dhanwantari Nagar, Puthiyakavu, Tripunithura, Ernakulam, Kerala, 682301 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Tripunithura |
| Address |
Government Ayurveda College and Hospital, Dhanwantari Nagar, Puthiyakavu, Tripunithura, Ernakulam, Kerala, 682301 |
| Type of Sponsor |
Other [Government Ayurveda College] |
|
|
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 Vinuraj S |
Government Ayurveda College and Hospital,Tripunithura |
Department of Swasthavritta, Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura, Ernakulam,682301
Ernakulam
KERALA |
9447102737
drvinurajs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurveda College, Tripunithura, Kochi, Kerala- 682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N40||Benign prostatic hyperplasia. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: Yoga techniques, Procedure details: Loosening exercises-10-15mins, Training period-7 days, daily duration-45mins.
Yoga procedures- Tadasana,Utkatasana,Trikonasana, Gomukhasana,Mandukasana,Virasana,Pavanamuktasana,Setu bandhasana,Supta baddha Konasana, Viparita karini, Naukasana.
Mudras & Bandhas-Ashwini mudra, Moola bandha
Relaxation procedure- Shavasana)
| | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: Kegel exercise, Procedure details: Kegel exercise - sessions per day-2, 7 days training to hold contraction of pelvic muscles.
Pelvic floor relaxation with abdominal breathing before & after each kegel exercise sessions. )
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Participants aged 40 to 65 years
2.Diagnosed BPH cases with prostate volume between 25–80 cc (via USG) (mild to
moderate) and/or Post void residual volume above 100 ml will be included
3.IPSS score between 8–19 (mild to moderate)
4.Diagnosed with BPH and taking standard modern medication for atleast 4 months
5.Willing to participate in daily yoga sessions |
|
| ExclusionCriteria |
| Details |
1.Severe BPH (IPSS Score greater than 19)
2.Known case of Prostate cancer, neurogenic bladder, Urethral stricture, bladder stones or
history of prostate or pelvic surgery (other than for BPH)
3.Cognitive/neurological impairment
4.Active UTI
5.Uncontrolled diabetes mellitus, hypertension, cardiac, respiratory disorders
6.Participants not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in prostate volume and Post void residual urine in Yoga group or Kegel exercise group |
Before training
and on 91st day for both intervention group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in International Prostate symptom score |
Before training
31st day
61st day
91st day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/02/2026 |
| 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="1"
Months="6"
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
|
Benign Prostatic Hyperplasia (BPH) is a common age-related condition causing lower urinary tract symptoms that significantly affect quality of life. This comparative clinical trial aims to evaluate and compare the effect of selected yoga techniques and Kegel exercises when used as adjuncts to standard modern medical treatment in patients with mild to moderate BPH.A total of 50 patients aged 40–65 years, already on standard medical therapy for BPH, will be randomly allocated into two intervention groups using SNOSE randomization. Group A will receive selected yoga techniques for 45 minutes daily, and Group B will receive Kegel exercises for 20 minutes daily, both for a duration of 12 weeks in addition to their ongoing medication.Primary outcome measures include changes in prostate volume and post-void residual urine (PVRU) assessed by ultrasound. Secondary outcome includes changes in International Prostate Symptom Score (IPSS). Assessments will be conducted at baseline and at the end of the intervention period, with IPSS evaluated at regular intervals. |