Evaluation of the effect of oral formulation prepared from extract of pomegranate for treatment of benign prostate hyperplasia: A triple blind randomized clinical trial
Evaluation of the effect of oral formulation prepared from extract of pomegranate for treatment of benign prostate hyperplasia
Design
This is a randomized triple-blind, parallel group clinical trial on 40 patients with benign prostate hyperplasia (20 patients in treatment group and 20 patients in placebo group).
Settings and conduct
This study will perform on 40 patients with benign prostate hyperplasia who refer to Quem Hospital, Mashhad, Iran.They whether will received 3 capsules contain 250 mg of pomegranate peel extract daily for 4 month or placebo capsules in placebo group.
Participants/Inclusion and exclusion criteria
inclusion criteria: age between 50-80 y, clinical diagnosis of mild to moderate benign prostate hypertrophy (BPH) (IPSS<18)
exclusion criteria:
1-simultaneous use of BPH medications except tamsulosin
2-use of supplements which existing in BPH such as saw palmetto , vitamine E and Quercetin vitamines
3-having prostate or bladder cancer
4-history of prostate surgery
5-PSA>4mg/ml
6-Post void residue (PVR)≥200 ml
7-history of allergy to pomegranate and its derivatives
8-use of medications with considerable metabolism through Cytochrome 3A4
9- low blood pressure during treatment
10-pomegranate use by patients during study
11- Patient dissatisfaction
12- history of severe constipation or hemorrhoids
Intervention groups
Treatment group: 3 capsules contains 250 mg of peel pomegranate extract daily for 2 month, control group: 3 capsule contains lactose as placebo daily for 4 month
Main outcome variables
PSA serum level, prostate size, post void volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046990N4
Registration date:2020-07-29, 1399/05/08
Registration timing:registered_while_recruiting
Last update:2020-07-29, 1399/05/08
Update count:0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Sepideh Elyasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1588
Email address
elyasis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral formulation prepared from extract of pomegranate for treatment of benign prostate hyperplasia: A triple blind randomized clinical trial
Public title
Evaluation of the effect of oral formulation prepared from extract of pomegranate for treatment of benign prostate hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 50-80 years
Mild to moderate clinical diagnisis of BPH (patient has lower urinary (based on international prostate symptom score (IPSS)<18)
Exclusion criteria:
simultaneous use of BPH medications except tamsulosin
use of supplements which existing in BPH such as saw palmetto , vitamin E and Quercetin vitamins
having prostate or bladder cancer
history of prostate surgery
PSA>4mg/ml
Post void residue (PVR)≥200 ml
history of allergy to pomegranate and its derivatives
use of medications with considerable metabolism through Cytochrome 3A4
Age
From 50 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
capsules contain pomegranate peel extract and placebo capsules will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician and the pharmacy student. Data collection and analysis are performed by the pharmacy student and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Qureshi Building, Daneshgah street
City
mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MUMS.REC.1399.132
Health conditions studied
1
Description of health condition studied
benign prostate hyperplasia
ICD-10 code
N40.0
ICD-10 code description
Enlarged prostate without lower urinary tract symptoms
Primary outcomes
1
Description
PSA serum level
Timepoint
at the beginning of the study and after 4m
Method of measurement
laboratory measurement
2
Description
prostate size and post void volume
Timepoint
at the beginning of the study and after 4m
Method of measurement
sonography
3
Description
clinical assessment
Timepoint
at the beginning of the study and after 2 and 4m
Method of measurement
review and physical examination
Secondary outcomes
1
Description
adverse drug reaction assessment e.g. low blood pressure
Timepoint
at the beginning of the study and monthly
Method of measurement
review and physical examination
Intervention groups
1
Description
Intervention group: 3 capsules contain 250 mg of pomegranate peel extract, prepared in pharmaceutics laboratory of pharmacy school, daily for 4 month
Category
Treatment - Drugs
2
Description
Control group:3 placebo capsules with same appearance of capsules contain pomegranate peel extract, including lactose, daily for 4 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Quem hospital
Full name of responsible person
Sepideh Elyasi
Street address
Quem Hospital, Ahmadabad Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Faculty of Pharmacy, Ferdowsi University, Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1337
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Rezvan Danesh Danial company
Full name of responsible person
Ali Akhundi
Street address
Salon 1, Growth and technology center, Ghuzhd, Gonbad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691183151
Phone
+98 51 3180 1588
Email
rezaakhondi226@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rezvan Danesh Danial company
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Hossein Hasheminezhad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3851 7357
Email
HashemiNH941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The findings will be published in an article. Study protocol and statistical analysis will be used for article publication.
When the data will become available and for how long
One year after the end of the study it will be published and available in databases.
To whom data/document is available
If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers.
Under which criteria data/document could be used
The other researchers can use our findings in their review articles and meta analysis.
From where data/document is obtainable
For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks