| CTRI Number |
CTRI/2025/09/095011 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Dhanyaka Gokshura Ghrita and Varunadi Kwath in the management of Vatastheela (Mutravaha srotas vikara)(Benign Prostate Hyperplasia) |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of Dhanyaka Gokshura Ghrita And Varunadi Kwath In The Management Of Vatastheela W.s.r To 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 |
Dr Prince kumar Singh |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya, Khurja Bulandshahr |
| Address |
OPD NO 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9897335669 |
| Fax |
|
| Email |
princethakur1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Nayak |
| Designation |
MS Shalya Professor of Department of Shalya Tantra |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya, Khurja Bulandshahr |
| Address |
OPD NO 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
77409 31315 |
| Fax |
|
| Email |
shikhanayak24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Dwivedi |
| Designation |
Principal/ Professor of Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya, Khurja |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya, Khurja Bulandshahr |
| Address |
OPD NO 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8957631677 |
| Fax |
|
| Email |
vydsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Prince Kumar Singh |
| Address |
OPD no 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
| 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 Prince Kumar singh |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
OPD no 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya
Bulandshahar
UTTAR PRADESH |
9897335669
princethakur11995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
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 | Drug | Classical | | (1) Medicine Name: Dhanyaka gokshura ghrita, Reference: bhavaprakasha chapter 36 shloka no 41, Route: Oral, Dosage Form: Ghrita, Dose: 24(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi kwatha, Reference: bhaishajya ratnavali chapter 32 shloka 39-41, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Male patients above 50 years and under 70 years of age
Classic symptoms of Vatashthila
Dysuria associated with B.P.H
Patient consent is considered
BPH weight in grams should be less than 70 gms
|
|
| ExclusionCriteria |
| Details |
Patient with HIV, HbsAg, HCV
Patients not suffering from HTN, DM
Patients with renal, ureteral and urethral disorders such as hydronephrosis and ureter are excluded
Previous T.U.R.P or any surgery involving the bladder and urethra
Enlargement of the prostate gland and complete obstruction of the urinary stream |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in urgency,frequency and straining of urine |
21 days
The trial drug will be given for 21 days with anupana and final follow up will be done after cessation of medicine i.e. after 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in nocturia and incomplete emptying of bladder |
After analyzing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.
Partially improvement after 7 days patient gets 30-40 percent relief from sign and symptoms
Improvement after 14 days patient gets 60-70 percent relief from sign and symptoms
Cured after 21 days patient gets 80-100 percent relief from sign and symptoms |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="10"
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
|
A technical entity of Mutravaha srotas where in the hindrance to the flow of urine is
found.Out of 12 mutraghata explained, Vatastheela is considered for the obstruction of the flow of urine by means of Ashthilavat granthi
that is enlarged prostatic gland. There are several drugs for Vatastheela but here I have chosen comparative study between two single drugs i.e. Varunadi kwath and Dhanyaka gokshura ghrita which does not only treat its symtoms but also does samprapti bhanga. Therefore I have selected 60 patients aged between 50-70 years, patient should be selected on the basis of inclusion and exclusion criteria. The trial will be of 21 days and follow up will be done after each week. Cured after 21 days patient gets 80-100percent relief from signs and symptoms |