| CTRI Number |
CTRI/2024/10/074894 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment for Enlarged Prostate |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate The Efficacy of Shilobidadi Tailam Uttarabasti and Shilobidadi Tailam Matrabasti Followed by Shilodbidadi Kashayam in the Managment of Vatastila with special refference to 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 |
DrMADHUSUDAN REDDY |
| Designation |
PANCHAKARMA POST GRADUATION |
| Affiliation |
Taranath goverment ayurvedic medical college and hospital,bellary.583101 |
| Address |
Taranath government ayurvedic medical college and hospital Panchakarma OPD Room number - 06
ballari
Bellary
KARNATAKA
583101
India |
| Phone |
7019139480 |
| Fax |
260273 |
| Email |
madhusudanreddynagwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRAJESH SUGUR |
| Designation |
MD(ayu) PROFESSOR AND HOD DEPARTMENT OF PANCHAKARMA |
| Affiliation |
Taranath goverment ayurvedic medical college and hospital,bellary.583101 |
| Address |
Taranath government ayurvedic medical college and hospital Panchakarma OPD Room number - 06
ballari
Bellary
KARNATAKA
583101
India |
| Phone |
9844457833 |
| Fax |
260270 |
| Email |
vdrsugur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRAJESH SUGUR |
| Designation |
MD(ayu) PROFESSOR AND HOD DEPARTMENT OF PANCHAKARMA |
| Affiliation |
Taranath goverment ayurvedic medical college and hospital,bellary.583101 |
| Address |
Taranath government ayurvedic medical college and hospital Panchakarma OPD Room number - 06
ballari
Bellary
KARNATAKA
583101
India |
| Phone |
9844457833 |
| Fax |
260270 |
| Email |
vdrsugur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pharmacy Section of Taranath Government Ayurvedic Medical College And Hospital. College building Ballari 583101 |
|
|
Primary Sponsor
|
| Name |
DrMADHUSUDAN REDDY |
| Address |
Taranath government ayurvedic medical college and hospital Panchakarma OPD Room number - 06
Ballari |
| 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 |
| DrMADHUSUDAN REDDY |
Taranath Goverment Ayurvedic Medical College and Hospital Bellary 583101 |
Taranath government ayurvedic medical college and hospital Hospital block, Panchakarma OPD Room number - 06
Ballari
Bellary
KARNATAKA |
7019139480
260273
madhusudanreddynagwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TGAMCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N398||Other specified disorders of urinary system. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: CHARAK SIDDHISTHANA , Procedure details: MATRA BASTI WITH SHILODBIDADI TAILA 72 ML FOR 16 DAYS )
(1) Medicine Name: SHILODBIDADI KASHAYAM, Reference: BHAISHEJYA RATNAVALI, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 20 Days | | 2 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: CHARAKA SIDDISTHANA , Procedure details: UTTARA BASTI WITH SHILODBIDADI TAILA 45 ML ADDMINISTERED UNDER A SEPTIC MEASURES FOR 9 DAYS WITH A GAP OF THREE DAYS FOR EVERY THREE DAYS)
(1) Medicine Name: SHILODBIDADI KASHAYAM, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 20 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patient presenting clinical features of vatastila
Patient diagnosed with bph grade 1,grade 2 and grade 3
Patient having score mild to moderate in international prostate symptoms score will be included
Patient fit for basti karma
|
|
| ExclusionCriteria |
| Details |
Patient having ca of prostate,uti,urethral stricture,hematurie,uremia,renal failure
Patient having major systemic illeness like tb,uncontrolled diabetis mellitus
Patients with acute retention of urine who need surgical intervention
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from subjective parameters like pain in urinary bladder and difficulty in micturation,within 10 to 12 weeks |
Relief from subjective parameters like pain in urinary bladder and difficulty in micturation
within 10 to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the size reduction of prostate
Improvement in post voidal residual urine volume via usg
|
42 DAYS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="1"
Days="12" |
|
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 Prostate Hyperplasia (BPH) is a benign enlargement of prostate which occurs after 50 years. Usually between 60 and 70 years with age testosterone level drops slowly, but fall of estrogen level is not equal. The prostate enlarges through intermediate peptide growth factor, so that increases pressure on the urethra and results in urinary symptoms, such as increased frequency of micturition, Dysuria and urgency. Prevalence of BPH shows 20% in men aged 41–50yrs, 50% in men aged 51–60yrs and >90% in men older than 80yrs. At age 55yrs, approx. 25% of men report obstructive voiding symptoms, at the age of 75yrs, 50% of men complain of a decrease in the force of their urinary stream Hence It is the need of the hour to understand BPH in terms of Ayurveda, so that an uncomplicated and patient friendly treatment can be advised to the patients. Thus, Shilodbidadi tailam Uttara Basti & Matra Basti followed by Shilodbidadi Kashayam as a shamana aushadhi in both groups are adviced. Keeping all these facts in mind,“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHILODBIDADI TAILAM UTTARABASTI AND SHILODBIDADI TAILAM MATRABASTI, FOLLOWED BY SHILODBIDADI KASHAYAM IN THE MANAGEMENT OF VATASTHILA WITH SPECIAL REFERENCE TO BENIGN PROSTATIC HYPERPLASIA†is undertaken. |