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
|
|
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
|
|
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. |