| CTRI Number |
CTRI/2025/04/085519 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management for BPH |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Dashmool Sidha Taila Uttar Basti and Matra Basti in the management of Vat Ashthila wsr to Benign Prostate Hyperplasia (BPH) |
| 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 Pratibha Ola |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
PG Scholar
PG Department of Shalya Tantra
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005696012 |
| Fax |
|
| Email |
pratibhaola11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Associate Professor
PG Department of Shalya Tantra
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Associate Professor
PG Department of Shalya Tantra
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan India PIN 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Rada ji Circle Ambamata scheme Udaipur Rajasthan PIN 313001 |
| Type of Sponsor |
Government medical 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 Pratibha Ola |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
OPD No 1 and 8
PG Department of Shalya Tantra
Associated group of Hospitals Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN |
8005696012
pratibhaola11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
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 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charaka Samhita, Procedure details: Matra Basti will be given for 7 days followed by a gap of one week
Same procedure will be repeated up to 4 weeks)
(1) Medicine Name: Dashmool Sidha Taila, Reference: Sushruta Samhita, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 4 Weeks | | 2 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charaka Samhita, Procedure details: Uttar Basti will be given for 7 days followed by a gap of one week
Same procedure will be repeated up to 4 weeks)
(1) Medicine Name: Dashmool Sidha Taila, Reference: Sushruta Samhita, Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
1) Patients suffering from sign and symptoms of Benign Prostate Hyperplasia
2) Residual urine should be less than 120 ml
2) Size of Prostate less than 40 cc |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from Uncontrolled Diabetes Mellitus Tuberculosis Hepatitis Prostatitis and Malignancy
2) Residual urine greater than 120 ml
3) Size of Prostate greater than 40 cc
4) Catheterized patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Improvement in sign and symptoms of Benign Prostate Hyperplasia
2) Reduction in size of Prostate
3) Residual urine volume |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Improvement in sign and symptoms of Benign Prostate Hyperplasia
2) Recurrence of Benign Prostate Hyperplasia |
1 month |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="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
|
This is an open labelled parallel group study. In this study, group A 30 patients will be administered with Dashmool Sidha Taila Uttar Basti for 7 days followed by a gap of 1 week for 28 days and group B 30 patients will be administered with Dashmool Sidha Taila Matra Basti for 7 days followed by a gap of 1 week for 28 days |