| CTRI Number |
CTRI/2026/03/105524 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic treatment for prostate enlargement |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the efficacy of vastyamayantaka ghrita uttara basti in the management of vatashteela(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 Pavan Janagond |
| Designation |
Post graduate scholar |
| Affiliation |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal |
| Address |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal
Department of shalya tantra opd no.16
583231
Koppal
KARNATAKA
583231
India |
| Phone |
7411008088 |
| Fax |
|
| Email |
pavansj12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lohti kalal |
| Designation |
Associate professor and Guide |
| Affiliation |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal |
| Address |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal
Department of shalya tantra opd no.16
583231
Koppal
KARNATAKA
583231
India |
| Phone |
7090116108 |
| Fax |
|
| Email |
dr.lohitkalal7108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lohit kalal |
| Designation |
Associate professor and Guide |
| Affiliation |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal |
| Address |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal
Department of shalya tantra opd no.16
583231
Koppal
KARNATAKA
583231
India |
| Phone |
7090116108 |
| Fax |
|
| Email |
dr.lohitkalal7108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital,Gavimath campus,koppal |
|
|
Primary Sponsor
|
| Name |
Dr Pavan Janagond |
| Address |
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal
Department of shalya tantra opd no.16
583231 |
| 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 Pavan Janagond |
Shri Jagadguru Gavisiddeshwar Ayurvedic medical college and hospital Koppal |
PG studies in department of shalya tantra opd no.16
Koppal
KARNATAKA |
7411008088
pavansj12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree jagadguru gavisiddeshwar ayurvedic medical college koppal |
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: Vastyamayantaka ghrita, Reference: Sahasrayoga yoga ghrita prakarana sloka number 21, Route: Urethral, Dosage Form: Ghrita, Dose: 25(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: 25 ml for 3 days with gap of 7 days upto 1 month | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Tamsulosin 0.4mg | Tab Tamsulosin 0.4 mg 1 HS per orally for 1 month |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Patient with signs and symptoms of Vatashteela (Benign Prostatic Hyperplasia) and
IPSS (International Prostate Symptom Score ) less than 19.
Patient with age group between 50 t o 80 years.
USG o f Abdomen and pelvis prostate suggestive o f increased weight upto 80gm
Patient who willing t o give written Informed consent were included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with malignancy of prostate will be excluded.
Patients with severe urinary tract infection, urethral stricture will be excluded.
Patients with severe cardio vascular, renal or hepatic disorders.
Hypertension (more than 160 100mmHg) & Diabetes mellitus (RBS more than 250mgdl) are excluded.
Patients with immune compromised diseases will be excluded.
Patients with US findings suggestive of Hydroureteronephrosis are excluded.
PSA valuve more than 4ngdl |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Size of prostate
2 Post Void Residual volume (PVR)
3 Incomplete emptying
4 Frequency
5 Intermittency
6 Urgency
7 Weak stream
8 Straining
9 Nocturia
the above mentioned symptoms will be reduced after the study |
Assessment days 10th 20th 30th day according to IPSS or AUASI scale
Follow up on 60th day
Total study duration is 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Size of prostate
2 Post Void Residual volume (PVR)
3 Incomplete emptying
4 Frequency
5 Intermittency
6 Urgency
7 Weak stream
8 Straining
9 Nocturia
The above mentioned symptoms will be reduced after the study & the patient will be relieved |
The Assessment days are on 10th 20th 30th day
Follow up on 60th day
Total study duration is 60 days according to IPSS or AUASI scale |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="0"
Months="6"
Days="10" |
|
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
|
Benign prostatic hyperplasia is benign enlargement of prostate and affects both glandular epithelium and connective tissue stroma. It presents with features of incomplete emptying of urine, urgency, hesitancy, increased frequency and difficulty in micturition. It is a disease process with a well defined age incidence and occurs after 50 years. The prevalence of Benign Prostatic Hyperplasia increases after the age of 40 years, with a prevalence of 8percent to 60percent at the age of 90 years. In Ayurveda, Mutraghata is considered as Mutravarodha. It occurs due to Pratiloma gati of vata dosha in basti resulting in avarodha of Mutravaha srotas. It causes Vibandhata, Krichrata and Alpata of mutra. Acharya Sushruta has explained Mutraghata in Uttara tantra and symptoms of Mutraghata specifically Vatashteela can be closely resembled to Benign Prostatic Hyperplasia. In contemporary science use of Tamsulosin (5 a Blocker) is mentioned as one of the conservative management of Benign Prostatic Hyperplasia which are having side effects like orthostatic hypotension, dizziness, depression and gynaecomastia. Trans Urethral Resection of Prostate (TURP) is the primary surgical approach for Benign Prostatic Hyperplasia which has postoperative complications like hemorrhage, recurrence erectile dysfunction, urethral stricture, etc. Under these circumstances, it is a great need of hour to introduce novel, cost effective, safe and effective treatment modalities to treat the patients of Benign Prostatic Hyperplasia. In Mutraghata chikitsa, Acharya Sushruta, in Uttara tantra has mentioned Uttara basti as one of the prime treatment for the management of Mutraghata and he has also mentioned use of Kashaya, Kalka, Ghrita etc. which are having properties of Mutrala and Kaphamedahara. In Sahasrayoga Ghrita prakarana, Vastyamayantaka ghrita has been indicated in all types of Mutraghata by providing VataPittahara karma by the virtue of combination of ingredients present in It. Hence Vastyamayantaka ghrita is taken for Uttara basti over Tamsulosin in the management o f Mutraghata (Vatashteela). |