CTRI Number CTRI/2011/06/001797 [Registered on: 10/06/2011] Trial Registered Retrospectively
Last Modified On: 07/02/2013
Post Graduate Thesis No
Type of Trial Interventional
Type of Study
Drug
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study
Evaluation of Prostacare EF (Excipient free)
In benign prostatic enlargment
Scientific Title of Study
A double blind placebo control clinical trial to
Evaluate the efficacy of
Prostacare EF
In benign prostatic hypertrophy
Trial Acronym
Secondary IDs if Any
Secondary ID Identifier
HDC/CP/PP/093/2010
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name Dr A K Singh
Designation Principal & Professor & Head, Department of Kayachikitsa
Affiliation
Address Department of Kayachikitsa,
Shubhdeep Ayurved Medical College,
Indore
Phone 08022169999
Fax
Email doctoraksingh@yahoo.com
Details of Contact Person
Name
Dr A K Singh
Designation Principal & Professor & Head, Department of Kayachikitsa
Affiliation
Address Department of Kayachikitsa,
Shubhdeep Ayurved Medical College,
Indore
Phone
Fax
Email doctoraksingh@yahoo.com
Details of Contact Person
Name Dr A K Singh
Designation Principal & Professor & Head, Department of Kayachikitsa
Affiliation
Address Department of Kayachikitsa,
Shubhdeep Ayurved Medical College,
Indore
Phone
Fax
Email doctoraksingh@yahoo.com
Source of Monetary or Material Support
The Himalaya Drug Company
Primary Sponsor
Name The Himalaya Drug Company
Address Makali, Bangalore 562 123
Type of Sponsor Pharmaceutical industry-Global
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 A K Singh
Shubhdeep Ayurved Medical College
Shuvdeep Ayurved Medical College, Khandwa road, Indore
08022169999
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee Approval Status
Ethics Committee (EC)
Approved
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied
Health Type Condition
Patients
Benign prostatic hypertrophy,
Intervention / Comparator Agent
Type Name Details
Comparator Agent
Placebo
Dose - 2 capsule of placebo twice daily
Duration - 3 months
Mode of administration - oral
Intervention
Prostacare EF
Dose - 2 capsule of Prostacare EF twice daily
Duration of treatment - 3 months
Mode of administration - oral
Inclusion Criteria
Age From 40.00 Day(s)
Age To 60.00 Day(s)
Gender Male
Details Males between 40-60 years of age suffering from benign prostatic hypertrophy.
ExclusionCriteria
Details Males less than 40 years old are excluded from the trial.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome TimePoints
Improvement in the symptoms of BPH as measured by American Urological Association (AUA) symptom score.
3 months
Secondary Outcome
Outcome TimePoints
Assessment of long term safety of the study drug.
3 months
Target Sample Size
Total Sample Size= "40"Sample Size from India= "40" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)= ""
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
07/06/2011
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= "1"Months= "0"Days= "0"
Recruitment Status of Trial (Global)
Modification(s)
Not Applicable
Recruitment Status of Trial (India) Completed
Publication Details
Not applicable
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Male subjects aged between 40 to 60 years with Benign Prostatic Hypertrophy diagnosed on the basis of mild
to moderate symptoms of urinary obstruction, decreased maximal urinary flow
rates and an enlarged prostate gland on digital rectal examination will be
selected for a double-blind-placebo controlled study. The aim of this study is to evaluate the
efficacy of Prostacare EF in BHP.
All
patients satisfying inclusion criteria will be enrolled in this study. Men will be randomly assigned to receive 2
Capsule of Prostacare EF or placebo twice daily according to the randomisation
chart. All the patients will be
monitored at monthly interval for 3 months.
They will be evaluated for symptoms and urinary flow rates every month.
The primary end point, the symptom score will be
measured by American Urological Association (AUA) symptom score.