| CTRI Number |
CTRI/2020/12/030110 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bala Taila Matra Basti in the management of Mootraghata(Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
Efficacy of Varunashigravadi Ghanavati with Bala Taila Matra Basti in the management of Mootraghata(Benign Prostatic Hyperplasia)- An open labelled randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Talsaniya |
| Designation |
Pg Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda GAU |
| Address |
Shalya Tantra Department 6th floor
Institute for Post Graduate Teaching and Research in Ayurveda GAU
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7984969783 |
| Fax |
|
| Email |
ajtalsaniya32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish j Talsaniya |
| Designation |
PG Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda GAU |
| Address |
Shalya Tantra Department 6th floor
Institute for Post Graduate Teaching and Research in Ayurveda GAU
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7984969783 |
| Fax |
|
| Email |
ajtalsaniya32@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Associate professor Shalya Tantra Department IPGT and RA Jamnagar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda GAU JAMNAGAR |
| Address |
Shalya Tantra Department 6th Floor Academic Building
Institute for Post Graduate Teaching and Research in Ayurveda GAU
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
dudhamal@ayurveduniversity.com |
|
|
Source of Monetary or Material Support
|
| Shalya Tantra Department 6th Floor Academic Building
Institute for Post Graduate Teaching and Research in Ayurveda GAU,Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurved University |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurved University opposite city B Division police station PN marg
jamnagar 361008
gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ashish J Talsaniya |
Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar 361008 |
6th floor Academic Building Shalya Tantra Department IPGT and RA Jamnagar
Jamnagar
GUJARAT |
7984969783
ajtalsaniya32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute for Post Graduate Teaching and Research in Ayurveda GAU |
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: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A |
In group A patient was treated with varunashigravaadi Ghanavati 500 mg 2 vati TDS orally and Bala Tail Matra Basti 60 ml OD in a day for 1 month |
| Comparator Agent |
GROUP B |
Tamsulosin capsule 0.4 mg orally BD in a day for 1 month |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
The patients between 50-70 years of age
The patients having 3 or more than 3 signs and symptoms of Mootraghata(Benign Prostatic Hyperplasia)
Controlled Hypertension (BP less than 150-90 mmHg), diabetes mellitus (RBS less than 140 mg/dl)
|
|
| ExclusionCriteria |
| Details |
Patients of age below 50 years and above 70 years
Patients of malignancy, congenital deformities of urogenital tract or any abdominal-pelvic pathology other than BPH
Systemic diseases like chronic renal failure (CRF), Uncontrolled Hypertension (BP>150-90), diabetes mellitus (RBS >140)
Patients having Hematuria(Blood in the urine) , Bladder infection(UTI), kidney stone, Bladder stone
PSA level above 4.0 ng/ml
Patients k/c/o Tuberculosis, Paralysis, and Parkinsonism will be excluded
Known case of cardiac diseases (H/o- MI, IHD)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prostate size reduced
decrease in PSA level |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of BPH and also improvement in quality of life |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/01/2021 |
| Date of Study Completion (India) |
02/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In the clinical study, a
total of 40 patients with BPH were selected and divided randomly into two
groups In group-A treated with Varunashigravaadi
Ghanavati with Bala Taila Matra and In group B was treated with Capsule
Tamsulosin (0.4 mg) orally. Both groups divided according to a
computer-generate randomization chart among them 40 patients completed the
treatment as well as follow up. All the patients were assessed as per
subjective and objective criteria adopted during the study and the findings
were recorded in the research proforma.
In group-A Varunashigravaadi Ghanavati with Bala
Taila Matra Basti, highly significant result was observed in average urine
flow rate (UFR), enlarged prostate size & volume whereas no significant
result was found in post voidal residual urine (PVRU) volume.
In
group B Capsule Tamsulosin (0.4 mg) orally, highly significant result was observed
in Objective parameters i.e., average urine flow rate (UFR), size of the
enlarged prostate & prostate volume, and post voidal residual urine (PVRU) volume.
Statistically,
a significant result was noted on Subjective Parameter i.e. increased
frequency, nocturia, weak stream, incomplete voiding, and urgency in the
patients of both groups. |