| CTRI Number |
CTRI/2025/10/095530 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Dashmooladi Ghanvati and Gokshuradi Ghanvati for the Management of Vatashtheela (Benign Prostatic Hyperplasia) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Dashmooladi Ghanvati and Gokshuradi Ghanvati in Vatashtheela (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 |
Pushpa Patel |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand |
| Address |
OPD No 7 Department of Shalya Tantra Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand 249404
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7415636792 |
| Fax |
|
| Email |
pushpapatel30697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Sharma |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand |
| Address |
OPD No 7 Department of Shalya Tantra Uttarakhand Ayurved University Gurukul campus Haridwar Uttarakhand 249404
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9927067792 |
| Fax |
|
| Email |
drpankajsharma21@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pushpa Patel |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand |
| Address |
OPD No 7 Department of Shalya Tantra Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand 249404
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7415636792 |
| Fax |
|
| Email |
pushpapatel30697@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Shalya Tantra, Uttarakhand Ayurved University, Gurukul Campus Haridwar, Uttarakhand, India 249404 |
|
|
Primary Sponsor
|
| Name |
Pushpa Patel |
| Address |
OPD No 7 Department of Shalya Tantra Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand India 249404 |
| 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 Pushpa Patel |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
OPD No 7 PG Department of Shalya Tantra
Hardwar
UTTARANCHAL |
7415636792
pushpapatel30697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmooladi Ghanvati, Reference: Yogaratnakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Ghanvati, Reference: Yogaratnakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1 Patients presenting with clinical signs and symptoms of Vatashtheela (BPH)
2 Controlled case of Hypertension and Diabetes Mallitus
3 Age between 50-80 years
4 Prostate size (volume) upto 100cc
|
|
| ExclusionCriteria |
| Details |
1 Patients with any malignancy
2 Patients with other systemic diseases like Tuberculosis, Renal Failure, HIV, HBsAg, Urethral stricture etc
3 Bladder neck Stenosis and Hypertrophy
4 Prostatic calculi
5 Patients with Acute Retention of urine who need surgical intervention
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in subjective parameters
1 Vidsanga (can be correlated with constipation)
2 Vasti vedana (pain felt during micturition)
3 Incomplete emptying
4 Frequency of urination (in daytime)
5 Intermittency of urine stream
6 Urgency of micturition
7 Weak stream of urine
8 Straining
9 Nocturia
|
Assessment will be done at an interval of 45 days i.e. on 0 day, 45th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in objective parameters
1 Mutrasanga (Post Voidal Residual Volume)
2 Prostate size (volume)
3 Adhamana (bladder size or volume)
|
Assessment will be done at an interval of 45 days i.e. 0 day, 45th Day & 90th Day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
13/10/2025 |
| 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="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
|
This study is standard controlled clinical evaluation of Dashmooladi Ghanvati and Gokshuradi Ghanvati in Vatashtheela in age group 50-80 years for the duration of 90 days. The study will be conducted at UAU, Gurukul campus, Haridwar on 32 patients. In this study 16 patients will be administered with Dashmooladi Ghanvati and 16 patients will be administered with Gokshuradi Ghanvati for 90 days. Assessment will be done on the basis of subjective and objective parameters. The study will be conducted at OPD/IPD level of PG Department of Shalya Tantra. The assessment will be done at interval of 45 days of clinical trial and results obtained will be tabulated and statistically analyzed using appropriate tests.
|