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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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