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CTRI Number  CTRI/2016/04/006824 [Registered on: 13/04/2016] Trial Registered Retrospectively
Last Modified On: 07/08/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of herbal drug, Uricare tablet in patients with Prostate Enlargement 
Scientific Title of Study   A randomized open label, Placebo controlled phase II, Clinical study of uricare tablet for its action prostate enlargement 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrManish Patel 
Designation  Reader, Department of KAYACHIKITSA 
Affiliation  P.D.Patel Ayurvedic Hospital, Nadiad 
Address  P.D.Patel Ayurvedic Hospital College Road Nadiad

Kheda
GUJARAT
387001
India 
Phone    
Fax    
Email  manishayu97@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DrManish Patel 
Designation  Reader, Department of KAYACHIKITSA 
Affiliation  P.D.Patel Ayurvedic Hospital, Nadiad 
Address  P.D.Patel Ayurvedic Hospital College Road Nadiad

Kheda
GUJARAT
387001
India 
Phone  09979589865  
Fax    
Email  manishayu97@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrManish Patel 
Designation  Reader, Department of KAYACHIKITSA 
Affiliation  P.D.Patel Ayurvedic Hospital, Nadiad 
Address  P.D.Patel Ayurvedic Hospital College Road Nadiad

Kheda
GUJARAT
387001
India 
Phone  09979589865  
Fax    
Email  manishayu97@yahoo.com  
 
Source of Monetary or Material Support  
PETLAD MAHAL AROGYA MANDAL PHARMACY, PIPLATA 
 
Primary Sponsor  
Name  PETLAD MAHAL AROGYA MANDAL PHARMACY 
Address  At& Post Piplata-387355 Ta- Nadiad 
Type of Sponsor  Other [Ayurvedic Industries] 
 
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 Manish Patel  P.D.Patel Ayurvedic Hospital, Nadiad  Department of KAYACHIKITSA
Kheda
GUJARAT 
09979589865

manishayu97@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
J S Ayurved Mahavidhyalaya & P D Patel Ayurvedic Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from the Benign prostatic hyperplacia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Tablet  Placebo contain starch powder tablet Dose: 2 tablet twice a day Route of administration: orally Duration of treatment: 6 weeks 
Intervention  Uricare Tablet  It contains Ext. Crataeva religiosa, Ext. Boerhavia diffusa, Ext. Tinospora cordifolia, Shuddha Shilajit, Commiphora mukul Dose: 2 tablet twice a day Route of administaration: Orally Duration of Treatment: 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  Patients having symptoms like Difficulty starting urine stream, Weal flow of urine, Dribbling of urine, Dysuria, Feeling like bladder is not completely empty are included for the study. 
 
ExclusionCriteria 
Details  Patients already having Hypertension, Suffering from auto immune disorder, Spastic or genetic disorder, and also on long term steroidal treatment, who is not willing to fill Informed consent form, are excluded from the trial 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The predefined primary end points are rapid symptomatic relief from Prostate Enlargment, Hypertention, and Urolithiasis.  in 6 weeks of time period 
 
Secondary Outcome  
Outcome  TimePoints 
The predefined secondary endpoints are short- and long-term safety, and overall compliance to the drug treatment  in entire study time and also on follow up visits 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/10/2015 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The current trial is performed to evaluate the efficacy and safety parameters of the Poly herbal tablet formulation which is administered to the patients suffering from the prostate enlargement foe 6 weeks of time. it is also expected to produce the beneficiary effect in treatment of the urolithiasis, Hypertension and also urinary tract infection. Patients are open to recruit at P.D.Patel Ayurvedic Hospital, Nadiad under the supervision of the Dr. Manish Patel (PI). The patients are randomized by computerized system. half of the patients received the poly herbal drug whereas remaining patients received the placebo. the patients are expected to examined after the 6 weeks of the trial for the efficacy and safety parameters. 
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