Comparison of pomegranate peel extract oral formulation and soft capsule including Cucurbita pepo oil and vitamin E for treatment of benign prostate hyperplasia
Comparison of the effect of oral formulation prepared from extract of pomegranate with soft capsule including Cucurbita pepo oil and vitamin E for treatment of benign prostate hyperplasia
Design
This is a randomized single blind, parallel group clinical trial on 40 patients with benign prostate hyperplasia (20 patients in treatment group and 20 patients in control group).
Settings and conduct
This study will perform on 40 patients with benign prostate hyperplasia who refer to Quem Hospital or private clinic of of the executor of the project, Mashhad, Iran.They whether will received 3 capsules contain 250 mg of pomegranate peel extract daily for 4 month or prostabarij capsules once daily in control group. This study will be single blind and just analyzer will be blind. Data will be inserted in spss file as A or B code.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1-age between 50-80 y
2-clinical diagnosis of mild to moderate benign prostate hypertrophy (BPH) (IPSS lower than18)
not including criteria: 1-simultaneous use of BPH medications except tamsulosin 2-use of supplements which existing in BPH such as saw palmetto and Quercetin 3-PSA above 4 mg/ml 4-Post void residue (PVR) higher or equal to 200 ml 5-history of allergy to pomegranate and its derivatives
Intervention groups
Treatment group: 3 capsules contains 250 mg of peel pomegranate extract daily for 2 month, control group: one 390mg prostabarij capsules including vitamin E and Cucurbita pepo oil capsule c 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:IRCT20200408046990N8
Registration date:2021-09-23, 1400/07/01
Registration timing:registered_while_recruiting
Last update:2021-09-23, 1400/07/01
Update count:0
Registration date
2021-09-23, 1400/07/01
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
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pomegranate peel extract oral formulation and soft capsule including Cucurbita pepo oil and vitamin E for treatment of benign prostate hyperplasia
Public title
comparison of pomegranate peel extract capsule effect with prostabarij soft capsule in patients with benign prostate hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 50-80 years
Mild to moderate clinical diagnosis 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, 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
concomitant use of warfarin in both group and statins except rosuvastatin, tacrolimus, and cyclosporine in pomegranate group
Patient dissatisfaction
Age
From 50 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 10 blocks from Quadruple blocks and finally 40 patients will enter the study. Allocation concealment method: Use of the central service, which consists of people who work in the center and have no knowledge of the researchers and will make a secret allocation for the research. In this method, based on the blocks created in the randomization method, a code is considered for each patient, which will be provided to the researcher at the time of patient admission by a person who has no knowledge of the process of studies and statistical analysis.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will be inserted in SPSS software as A and B and after analyzing data by the analyzer the codes will be defined.
Placebo
Not 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
2021-09-01, 1400/06/10
Ethics committee reference number
IR.MUMS.REC.1400.160
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
Enzyme Immuno Assay
2
Description
prostate size
Timepoint
at the beginning of the study and after 4m
Method of measurement
sonography
3
Description
post void volume
Timepoint
at the beginning of the study and after 4m
Method of measurement
sonography
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 Mashhad pharmacy school, daily for 4 month
Category
Treatment - Drugs
2
Description
Control group: Prostabarij capsule including 390 mg vitamin E and Cucurbita pepo oil once daily for 4 months, standardized based on the presence of 230-200 mg of linoleic acid and 30 mg of alpha tocopherol in each soft capsule produced by barijessence company.
Category
Treatment - Drugs
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
2
Recruitment center
Name of recruitment center
private office of Dr Darabi
Full name of responsible person
Mohammad Reza Darabi Mahboub
Street address
Second floor, poorsina building, east golestan avenue, Chamran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177944855
Phone
+98 51 3229 2300
Email
darabimmr@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
100
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
Person responsible for general 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 3851 7357
Email
elyasis@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
Asscociate 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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available