| CTRI Number |
CTRI/2025/10/095972 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic intervention for the management of vatashthila (Benign Prostate Hyperplasia) |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation Of Dhanyak Gokshura Ghritam Uttar Basti And Khadir Beej Choorna Orally In Vatashthila (Benign Prostate 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 |
Satinderpal Singh |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute Of Ayurveda and hospital roorkee haridwar |
| Address |
opd-1 Shalya Tantra Quadra Hospital Of Ayurveda Near Montfort School, Haridwar Road Roorkee, Dist Haridwar Uttarakhand
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9876949516 |
| Fax |
|
| Email |
satinderbhinder51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Singh Manhas |
| Designation |
Professor and HOD |
| Affiliation |
Quadra Institute Of Ayurveda and hospital roorkee haridwar |
| Address |
opd-1 Shalya Tantra Quadra Hospital Of Ayurveda Near Montfort School, Haridwar Road Roorkee, Dist Haridwar Uttarakhand
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9461940996 |
| Fax |
|
| Email |
dr.raji83@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Satinderpal Singh |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute Of Ayurveda and hospital roorkee haridwar |
| Address |
opd-1 Shalya Tantra Quadra Hospital Of Ayurveda Near Montfort School, Haridwar Road Roorkee, Dist Haridwar Uttarakhand
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9876949516 |
| Fax |
|
| Email |
satinderbhinder51@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Satinderpal Singh |
| Address |
Opd no 1 Shalya Tantra Quadra Hospital Near Montfort School Roorkee Haridwar |
| 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 |
| Satinderpal Singh |
Quadra Hospital of Ayurveda, Roorkee,Haridwar |
opd-1 ,Department of Shalya Tantra
Hardwar
UTTARANCHAL |
9876949516
satinderbhinder51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHAUDHARY HARCHAND SINGH ATMARAM EDUCATION TRUST QUADRA INSTITUTE OF AYURVEDA Quadra Hospital, Near Montfort School, Haridwar Road, Roorkee, Distt. Haridwar (Uttarakhand |
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. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Ayurveda Deepika commentary, Charaka Samhita Siddhi Sthana 9/50-57, Chaukhambha Orientalia, Varanasi, Reprint 2012; 1078p, Procedure details: • Position: The patient is made to relax and lay in a supine position.
• Drape the patient so that only the area around the penis is exposed.
• Wash the genitalia and the surrounding area with betadine by using sponge holding forceps and gauge.
• Retract the prepuce completely and thoroughly gently clean the glans penis with betadine.
• Cover the genitalia region with a sterile cutsheet.
• Autoclaved, Lukewarm 40 ml Dhanyak Gokshura Ghritam will be taken in the 50 ml syringe and the baby feeding tube of 8 no. attached to its tip (Care should be taken that all air in the syringe is expelled out before inserting into the urethra).
• The baby feeding tube will be lubricated with autoclaved oil.
• The flaccid penis will be held perpendicular to the body.
• The baby feeding tube will be placed in the external meatus by holding it from its tips.
• A few drops of oil will be injected in order to lubricate the meatus, to aid the smooth passage of the baby feeding tube.
• Gently introduce the tip of the baby feeding tube into the urethra. The advancement of the catheter produces the least amount of discomfort.
• As the bulbo-membranous urethra is approached, the patient is asked to take slow breaths. (This helps to relax the patient and allow easy passage of the catheter. The catheter should never be forcefully inserted if any obstruction is met.)
• Resistance will be encountered at the prostatic sphincter. Pause and allow the sphincter to relax. Lower the penis and continue to advance the catheter.
• When the catheter passes through the prostatic sphincter into the bladder, the patient feels to urinate.
• Slowly inject the required quantity of medicine into the bladder.
• After injecting the medicine, will carefully remove the catheter allowing some quantity of medicine in the syringe.
• Anti-clockwise Abhyanga is to be done over the groin region.
• Advise patient to lie in the same position for 10 minutes.
Procedure will be done for 3 days with gap of three days for 4 consecutive cycles ))
(1) Medicine Name: DHANYAK GOKSHURA GHRITAM, Reference: Dr.Bulusu Sitaram, Ed.2014, Bhavaprkasa Of Bhavamisra, Chaukhambha Orientalia:Varanasi, Madhyam And Uttarakhanda Volume 2 Chapter No.(36/41), Route: Urethral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Duration: 21 Days(2) Medicine Name: KHADIR BEEJ, Reference: Dr.G.Prabhakara Rao,Ed.2014,Chakradatta, Chaukhamba Orientalia:Varanasi, Cikitsa Sangraha Of Chakrapanidatta, Chapter(33/12), Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Ayurveda Deepika commentary, Charaka Samhita Siddhi Sthana 9/50-57, Chaukhambha Orientalia, Varanasi, Reprint 2012; 1078p, Procedure details: PRADHANA KARMA: -
• Position: The patient is made to relax and lay in a supine position.
• Drape the patient so that only the area around the penis is exposed.
• Wash the genitalia and the surrounding area with betadine by using sponge holding forceps and gauge.
• Retract the prepuce completely and thoroughly gently clean the glans penis with betadine.
• Cover the genitalia region with a sterile cutsheet.
• Autoclaved, Lukewarm 40 ml Dhanyak Gokshura Ghritam will be taken in the 50 ml syringe and the baby feeding tube of 8 no. attached to its tip (Care should be taken that all air in the syringe is expelled out before inserting into the urethra).
• The baby feeding tube will be lubricated with autoclaved oil.
• The flaccid penis will be held perpendicular to the body.
• The baby feeding tube will be placed in the external meatus by holding it from its tips.
• A few drops of oil will be injected in order to lubricate the meatus, to aid the smooth passage of the baby feeding tube.
• Gently introduce the tip of the baby feeding tube into the urethra. The advancement of the catheter produces the least amount of discomfort.
• As the bulbo-membranous urethra is approached, the patient is asked to take slow breaths. (This helps to relax the patient and allow easy passage of the catheter. The catheter should never be forcefully inserted if any obstruction is met.)
• Resistance will be encountered at the prostatic sphincter. Pause and allow the sphincter to relax. Lower the penis and continue to advance the catheter.
• When the catheter passes through the prostatic sphincter into the bladder, the patient feels to urinate.
• Slowly inject the required quantity of medicine into the bladder.
• After injecting the medicine, will carefully remove the catheter allowing some quantity of medicine in the syringe.
• Anti-clockwise Abhyanga is to be done over the groin region.
• Advise patient to lie in the same position for 10 minutes.
Procedure will be done for 3 days with gap of three days for 4 consecutive cycles ))
(1) Medicine Name: DHANYAK GOKSHURA GHRITAM, Reference: Dr.Bulusu Sitaram, Ed.2014, Bhavaprkasa Of Bhavamisra, Chaukhambha Orientalia:Varanasi, Madhyam And Uttarakhanda Volume 2 Chapter No.(36/41), Route: Urethral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Classical symptoms of Vatashthila, Diagnosed cases of BPH along with lower urinary tract symptoms, Age between 40-70 years, Grade 1 and 2 prostate enlargements
|
|
| ExclusionCriteria |
| Details |
Diagnosed cases of, Serology positive (hiv, hcv, hbsag) VDRL, Se.PSA value more than 4ng/ml, Prostate carcinoma, Renal failure, Recurrent UTI, Urethral stricture, Uncontrolled cases of hypertension, diabetes mellitus,Known case of bleeding disorders, Age less than 40 and more than 70 years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptomatic relief, decrease in IPSS scoring, decrease in residual urine volume |
subjective parameters will be checked after end of every cycle and objective parameters at the end of treatment of 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction Of Size Of Prostate |
Baseline to 21st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
·
Vatashthila A Type Of Mutraghata Chiefly Presents The Features
Related To The Lower Urinary
Tract Symptoms (LUTS)
And Can Be Co-Related With Benign Prostate
Hyperplasia (BPH) . The Aim Of This Study Is To Compare The Effectiveness Of Khadir
Beej Choorna Orally With Dhanyak Gokshura Ghritam Uttar Basti In Vatashthila
(Benign Prostate Hyperplasia)..Study Will Be Done In Two Groups Each Having 20
Patients . Group A Will Be Given Dhanyak Gokshura Ghritam Uttar Basti And In
Group B Dhanyak Gokshura Ghritam Uttar
Basti along with Khadir Beej Choorna Orally For 21 Days. Inclusion Criteria Is Classical Symptoms
Of Vatashthila ,Diagnosed Cases
Of BPH Along With Lower Urinary Tract Symptoms, Age Between 40-70 Years, Grade 1
And 2 Prostate Enlargements Whereas Exclusion Criteria Is Serology Positive (Hiv, Hcv, Hbsag) VDRL ,Se. PSA Value
> 4ng/Ml, Prostate Carcinoma, Renal Failure, Recurrent UTI ,Urethral Stricture ,Uncontrolled Cases
Of Hypertension, Diabetes Mellitus, Known Case Of Bleeding Disorders, Age Less
Than 40 And More Than 70 Years. Primary Outcome Will Be Symptomatic Relief
Along With Reduction In IPSS Score And Reduction In Residual Volume Whereas
Secondary Outcome Will Be Reduction In Prostate Size which will be observed by
USG findings |