| CTRI Number |
CTRI/2021/03/032260 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
BPH management by Ayurveda procedure by pushing oil in urethral opening |
|
Scientific Title of Study
|
Comparative clinical effect of Balataila as Uttara Basti and Matra Basti along with Kanchanar Guggulu in management of Mootraghata(Benign prostate hyperplasia)
A open label clinical trial
|
| Trial Acronym |
BPH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeraj Kumar |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Research and Teaching in Ayurveda |
| Address |
Department of Shalya Tantra ITRA Opposite Police B Division Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7231053235 |
| Fax |
|
| Email |
Ayurkaushalam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TS Dudhamal |
| Designation |
Associate Professor and HOD |
| Affiliation |
ITRA Jamnagar |
| Address |
Room no 628 6 floor Department of Shalya Tantra ITRA Opposite Police B Division Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TS Dudhamal |
| Designation |
Associate Professor and HOD |
| Affiliation |
ITRA Jamnagar |
| Address |
Room no 628 6 floor Department of Shalya Tantra ITRA Opposite Police B Division Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Research and Teaching in Ayurveda
Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Opposite B Division Police station ITRA Jamnagar |
| 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 |
| Neeraj Kumar |
Institute of Teaching and Research in Ayurveda Jamnagar |
OPD no 1 Department of Shalya Tantra OPD BLOCK Opposite Police B Division ITRA Jamnagar
Jamnagar
GUJARAT |
7231053235
Ayurkaushalam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: Mootravaha Srotas Vyadhi, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matra Basti |
Minimum 50 patients will be treated with Balataila as Matra Basti administrated through per rectal in dose of 60 ml daily once for one month along with oral administration of Kanchanar Guggulu of 500mg in tablet form thrice a day |
| Intervention |
Uttara Basti |
Minimum 50 patients will be treated with Balataila as Uttara Basti administrated through urethral route by feeding tube / by syringe in dose of 20 ml for 7 days with 7 days interval with total one month protocol along with oral administration of Kanchanar Guggulu of 500mg in tablet form thrice a day |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Grade 1 to Grade 3 BPH
2.Weight of prostate 30 to 85 gm
3.Patients having signs and symptoms of Mootraghata (BPH)
4.Patients with controlled diabetes mellitus
5.Patient with controlled blood pressure |
|
| ExclusionCriteria |
| Details |
1.Age below 40years and above 60 years
2.Grade 4 BPH
3.Weight of prostate more than 85 gm
4.Patients with uncontrolled Diabetes mellitus (FBS more than 140mg/dl PPBS more than 180mg/dl)
5.Patient of Uncontrolled Hypertension ICD-10(BP more than 140/90 mm of Hg)
6. Known case of cardiac diseases.
7. Patients of malignancy, congenital deformities of the urogenital tract, or any abdominopelvic pathology other than BPH
8. Tuberculosis Paralysis Parkinsonism etc will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of BPH |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of BPH |
2 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/03/2021 |
| Date of Study Completion (India) |
16/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The research study entitled “Comparative clinical effect of Balataila as Uttara Basti and Matra Basti along with Kanchanar Guggulu in management of Mootraghata (Benign prostate hyperplasia) A open-label clinical trial -[BPH] †Aim and Objective of this study was to compare the clinical effect of Balataila in the form of Uttara Basti and Matra Basti along with Kanchanar Guggulu orally in the management of Mootraghata(BPH). In this trial total of 100 Patients having signs & symptoms of Mootraghata will be divided into two groups 50 in each group by computer generated Random number table method. In Group A 50 Patients will be treated with Balataila Uttarbasti for the period of 7 days with 7 days interval along with oral medication of Kanchanar Guggulu 2 Tab Thrice a day for 30 days while in Group B 50 Patients will be treated with Balataila Matra Basti daily along with oral medication of Kanchanar Guggulu 2 Tab Thrice a day for 30 days. Follow will for 2 months in both the groups. Before treatment, routine hematological, biochemical, urine examination will be carried out. The assessment will be done after the completion of therapy in parameters including subjective and objective criteria like Urine flow rate (UFR), Post voidal residual urine (PVRU), and Size of prostrate by USG. Effect of therapy will be assessed statically after completion of study in stipulated time |