| CTRI Number |
CTRI/2019/07/020164 [Registered on: 12/07/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative clinical Study of Medicated Oil Enema by two different route of administration in Benign Prostate Hyperplasia |
|
Scientific Title of Study
|
An Open Lable Comparative Clinical Study Of Shilodbidadi Taila Uttara-Basti And Matra Basti In Mutraghata( B P H) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veeresh Sattigeri |
| Designation |
Assistant Professor |
| Affiliation |
RGES Ayurvedic Medical College Ron |
| Address |
RGES Ayurvedic Medical College
Department of Shalya Tantra
Division A
Room Number -7
First Floor
Abbigeri Road
Ron
Gadag
KARNATAKA
582209
India |
| Phone |
8748977781 |
| Fax |
|
| Email |
vaidhyashree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veeresh Sattigeri |
| Designation |
Assistant Professor |
| Affiliation |
RGES Ayurvedic Medical College Ron |
| Address |
RGES Ayurvedic Medical College
Department of Shalya Tantra
Division A
Room Number -7
First Floor
Abbigeri Road
Ron
Gadag
KARNATAKA
582209
India |
| Phone |
8748977781 |
| Fax |
|
| Email |
vaidhyashree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S A Patil |
| Designation |
Assistant Professor |
| Affiliation |
Ayurveda Mahavidyalaya Hubli |
| Address |
Ayurveda Mahavidyalaya Hubli
Department of Shalya Tantra
Division A
Ground Floor
Room Number 8
Heggeri Extension
Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
9448565198 |
| Fax |
|
| Email |
drsapatilms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya Hubli
Department of Shalya tantra
Room Number 8
Division A
Heggeri Extension
Hubli
District Dharwad
PIN 580024
|
|
|
Primary Sponsor
|
| Name |
Dr Veeresh Sattigeri |
| Address |
Ayurveda Mahavidyalaya Hubli
Heggeri Extension
Hubli
District Dharwad
580024 |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr S A Patil |
Ayurveda Mahavidyalaya Hubli
Department of Shalyatantra
Heggeri Extension
Hubli
pin 580024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Veeresh Sattigeri |
Ayurveda Mahavidyalaya Hubli |
Department of Shalya tantra
Ground Floor
Room Number 8
Heggeri Extension
Hubli 580024
Dharwad
KARNATAKA |
8748977781
vaidhyashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Ayurveda mahavidyalaya Hubli |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Uttarabasti |
Medicine : Shilodbhidadi taila
Dosage : 60ml
Time : Once in day(Approximately 9am to 10am)
Duration : 8 days
Gokshura kwatha orally: 30 ml bd 2 month from the day 1 of the treatment.
|
| Intervention |
Group B Matrabasti |
Medicine : Shilodbhidadi taila
Dosage : 60ml
Time : Once in day(Approximately 9am to 10am)
Duration : 8 days
Gokshura kwatha orally: 30 ml bd 2 month from the day 1 of the treatment.
|
| Comparator Agent |
Group C Gokshuradi Kwatha Oral |
Medicine: Gokshura kwatha
Dosage : 30 ml
Time : twice in day
Duration: 30ml bd 2 months
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patients with the clinical features of BPH (I-PSS Index)
Patients fit for Uttara basti and Matra basti
Digital rectal examination findings (BPH)
Ultrasonography findings suggestive of BPH.
Post voidal Residual urine volume more than 60 ml.
Uroflowmetry less than 15ml/sec.
Patient of Diabetes Mellitus less than 10 years of duration
|
|
| ExclusionCriteria |
| Details |
Patients with other causes of Uretheral stricture, Meateal Stenosis, phymosis calculus,
Sexual transmitted disorders
Un control Diabetic mellitus patients
HIV, HBsAg, patients, any prostate cysts, Acute urine retention, Heamaturia, significant bladder tenderness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Shilodbidai Taila Uttarabasti and Matrabasti in the management of Mutraghata |
1st day and 60th day of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of efficacy of Shilodbidai taila in the form of Uttarabasti and Matrabasti in the management of Mutraghata |
1st day and 60th day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1 |
|
Date of First Enrollment (India)
|
01/10/2019 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Benign Prostatic Hyperplasia
(BPH) is a most
common lower urinary tract disorder and it is the burning senile problem of elderly men of
age group between 50 to 70 years. The Incidence rate of BPH increase from 3
cases per 1000 men per year at the age 45–49 years, 38 cases per 1000 men per
year by the age of 75–79 years which shows the vulnerability of the disease at
terminal age. The treatment options in modern medicine by conservative
treatment using drugs i.e hormonal therapy has its complications like loss of
libido, impotency, gynecomastia etc surgical intervention like open prostatectomy,
Transurethral resection of Prostate (TURP), cryotherapy, Radio frequency
obliation,HIFU (high intensity focal ultrasound) etc have their own limitations . Hence There is a
increasing interest in less invasive techniques, and to find out a
suitable Ayurvedic approach, an
effort has been made towards the management of BPH. Considering the line
of management, the treatment methods which are adopted for Mutra vikaras, as Abhyanga,
Niruha Basti, Snehapana, Uttara Basti, Seka, Pradeha, Virechana etc are advised for all
varieties of Mutraghata The Shilodbhidadi Taila is indicated in Mutrakricchra, Mutraghata, Asmari Chikitsa
in the textbook of Bhaishajya ratnavali which is best Vatahara, Balya,
shota hara and Vedana shyamaka
With regard to this Shilodbhidadi taila is considered for this present clinical
study as Uttara basti and Matra basit in Mutragatha
(BPH) |