CTRI Number |
CTRI/2017/04/008306 [Registered on: 06/04/2017] Trial Registered Retrospectively |
Last Modified On: |
27/06/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Other |
Public Title of Study
|
Effect of Ushiradya Taila Matra Basti and Kanchanar Guggulu in the management of Mootraghata w.s.r to Benign Prostatic Hyperplasia |
Scientific Title of Study
|
Effect of Ushiradya Taila Matra Basti and Kanchanar Guggulu in the management of Mootraghata w.s.r to (Benign Prostatic Hyperplasia) An open labeled, randomized, comparative 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 |
Dr Bhagirath sankaliya |
Designation |
M S Scholar |
Affiliation |
IPGT RA Jamnagar Gujarat |
Address |
OPD No 1 Department of Shalya tantra IPGT and RA GAU
Jammagar GUJARAT OPD No 1 Department of Shalya tantra IPGT and RA GAU
Jammagar 361008 GUJARAT Jamnagar GUJARAT 361008 India |
Phone |
7698570056 |
Fax |
|
Email |
drbhagirath15@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr TS Dudhamal |
Designation |
Associate Professor |
Affiliation |
IPGT RA Jamnagar Gujarat |
Address |
6th floor Department of shalya tantra IPGT and RA GAU
Jammagar GUJARAT
Jamnagar GUJARAT 361008 India |
Phone |
9428671939 |
Fax |
|
Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr TS Dudhamal |
Designation |
Associate Professor |
Affiliation |
IPGT RA Jamnagar Gujarat |
Address |
6th floor Department of shalya tantra IPGT and RA GAU
Jammagar GUJARAT
Jamnagar GUJARAT 361008 India |
Phone |
9428671939 |
Fax |
|
Email |
drtsdudhamal@gmail.com |
|
Source of Monetary or Material Support
|
IPGT and RA GAU
Jammagar 361008 GUJARAT |
|
Primary Sponsor
|
Name |
IPGT and RA GAU Jammagar GUJARAT |
Address |
IPGT and RA GAU Jamnagar 361008 Gujrat India |
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 |
Dr Bhagirath Sankaliya |
IPGT RA GAU Jamnagar |
IPGT RA GAU Jamnagar 361008 Gujrat india Jamnagar GUJARAT |
7698570056
drbhagirath15@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
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 |
Age 40 years to 70years.
Patients having classical signs and symptoms of Mootraghata / BPH , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Kanchanar Guggulu |
For 21 days, with Luke warm water,1/2 an hour before meal |
Intervention |
Kanchanar Guggulu and Matra Basti |
1000 mg tablet tds For 21 days with Luke warm water half an hour before meal and Matra basti of Ushiradya taila For 21 days every morning |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Male |
Details |
Age 40 years to 70 years.
Patients having classical signs and symptoms of Mootraghata / BPH |
|
ExclusionCriteria |
Details |
Age below 40 years and above 70 years.
Patients of malignancy, congenital deformities of urogenital tract or any abdomino- pelvic pathology other than BPH.
Systemic diseases like Uncontrolled Hypertension and diabetes mellitus, Tuberculosis , Paralysis, Parkinsonism etc. will be excluded.
Known case of cardiac diseases.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
this work will useful in symptomatic treatment of BPH without surgery Progress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment |
21 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
this work will helps patients of BPH and give them symptomatic relief
Progress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment |
5 years |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 2 |
Date of First Enrollment (India)
|
14/02/2017 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
not yet publish |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In clinical study, patients were selected and divided randomly into two groups and treated with the trial formulations of kanchanar guggulu in group-A and Ushiradya Taila Matra Basti along with Kanchanar Guggulu in group-B. The treatment was instituted for the duration of 21 days. Out of 35 patients, 17 patients in both groups were completed the therapy as well as follow up period & 1 patient from group A was drop out due to diagnosis of carcinoma of prostate. All the patients were assessed as per subjective and objective gradation during the study & the findings were recorded in the research proforma. The entire study and its data related to effect of therapy were plotted after statistical calculations on all over the subjective & objective parameters. Ø Maximum improvement was seen in 1 patient (5.88%) and 2 patients (11.76%) in group A and B respectively. Ø Moderate improvement was seen in 6 patients (35.29%) and 8 patients (47.06%) in group A and B respectively. Ø Mild improvement was observed in 9 patients (52.95%) and 7 patients (41.18%) in group A and B respectively. Ø At the end of therapy, none of patient had got complete cure and 1 patient was seen unchanged (5.88%) result in group A. Ø Overall group B (47.99 %) has shown better result than group A (39.62 %) in all parameters. In subjective parameters(IPSS), group B had shown better result i.e. 83.69% than the group A (74.75%). But, when data was analyzed statistically with Wilcoxon Rank Sum Test (Mann Whitney), non significant difference between these groups was recorded. In all objective parameters group-B had shown better effect i.e. 50.44% than group-A (41.82%). But, when data was analyzed statistically with Unpaired ‘t’ test, insignificant difference between these groups was recorded. Finally study can be concluded that Kanchanar Guggulu orally and Ushiradya Taila Matra Basti is safe easy to apply and effective in symptomatic management of Mootraghata (BPH) without any side effect.
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