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CTRI Number  CTRI/2015/08/006095 [Registered on: 13/08/2015] Trial Registered Retrospectively
Last Modified On: 31/07/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of ayurvedic drugs in Benign enlargement of prostate gland 
Scientific Title of Study   A clinical study on kanchanar guggulu and matra basti of dhanyak gokshura ghrita in the management of mootraghata w.s.r. To BPH  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Joyal Patel 
Designation  M S scholar 
Affiliation  IPGT & RA 
Address  Department of Shalya Tantra, IPGTand RA Gujarat Ayurved University Jamnagar 361008

Jamnagar
GUJARAT
361008
India 
Phone  9824718110  
Fax  02882676856  
Email  drjoyal.patel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T S Dudhamal 
Designation  Assistant professor  
Affiliation  IPGT RA  
Address  Dept of Shalya tantra IPGT RA Gujarat Ayrveda University Jamnagar 361008

Jamnagar
GUJARAT
91
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T S Dudhamal 
Designation  Assistant professor  
Affiliation  IPGT RA  
Address  IPGT RA Dept of Shalya Tantra Jamnagar 361008

Jamnagar
GUJARAT
91
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
Source of Monetary or Material Support- Nil 
 
Primary Sponsor  
Name  IPGT RA  
Address  Institute of Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar 361008 
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 Joyal Patel  Institute of post graduate teaching and reaserch in ayurveda  OPD no 1 IPGT RA Guj Ayurveda University Jamnagar
Jamnagar
GUJARAT 		 9824718110

drjoyal.patel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from BPH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kanchanar Guggulu 500 mg tds orally   Kanchanar Guggulu 500 mg orally three times a day with luke warm water for 21 days will be given.  
Comparator Agent  Matrabasti- dhanyak gokshura ghrita   Matrabasti with 60ml dhanyak gokshura ghrita through rectal route will be given once daily for 21 days.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Patients having signs and symptoms of mootraghata and BPH
Age above 50 years 
 
ExclusionCriteria 
Details  Uncontrolled diabetes mellitus hypertension
Heart diseases
Any type of malignancy
Age below 50 years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The improvement will be assessed on the basis of international prostate symptom score
Average urine flow rate
Prostate size
Post voidal residual urine volume 
3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The improvement will be assessed on the basis of international prostate symptom score
Average urine flow rate
Prostate size
Post voidal residual urine volume
average urine flow rate 		 3 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/11/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   In this study 30 patients of BPH  were selected for study  and they were divided randomly in 3 groups. In group -A Dhanyaka Gokshur Ghrita was given as matra basti by rectal route for 21 days. In Group-B Kanchar Guggulu (Poly herbal drug in tab form) was given orally three times a day for 21 days. In Group-C Basti as well as Kanchar Guggulu  was given.The assessment was done on the basis of symptoms of enlared Benign Prosate and on the basis of IPSS (International Prostate Symptoms Score) prostate size PVRU (Post voided Residual Urine). In most of the patients the increased frequency was remarkably reduced. The Size o Prostate gland was remained same in most of the patients (80%), PVRU was reduced after treatment. Urine flow rate was increased in most of the patients. Overall the quality of life (QOL)  was improved in 70% of patients.  In group-A, symptomatic relief in symptoms like dribbling, dysurea, incomplete voiding, weak stream & increased frequency of micturition was found highly significant. In group-B maximum patients shown symptomatic complete relief (above 90%) in almost all symptoms and statistically found highly significant result.In patients of group-C, all patients showed symptomatic relief in all the symptoms and statistically showed highly significant result. The size and volume of prostate gland remained unchanged after completion of treatment in most of the patients and statistically insignificant result obtained. In case of post voidal residual urine volume in individual patients before and after, was markedly reduced by 72.16% In average urine flow rate, highly significant results were observed in group-B and significant results observed in group-A & group-C. The relief in the obstruction of urine flow might be due to improving the function of apana vayu.  Kanchanar Guggulu contains ascorbic acid which helps in relaxing the smooth muscle of bladder neck and prostate gland to relieve in pressure and improve the urine flow.   The study concluded that Group B had shown better result than group A and C. 
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