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Evaluation of the effect of hydroalcoholic extract of Elaeagnus angustifolia on oxidative stress and inflammatory markers in patients with mild to moderate Benign Prostatic Hyperplasia

Protocol summary

Study aim
this study will be conducted with the aim of the effect of EA fruit on the oxidant/antioxidant status in this disease.
Design
Clinical trial with control group, with factorial groups, double-blind, randomized, phase 3 on 96 patients. The Rand function of Excel software was used for randomization
Settings and conduct
In the context of the effect of hydroalcoholic extract of Sanjad on oxidant and antioxidant factors in patients with benign prostatic hyperplasia in the urology clinic of Shahid Muftah, Yasouj, in a double-blind randomization, including the researcher and the patients.
Participants/Inclusion and exclusion criteria
. Inclusion Men over 45 years old. Presence of lower urinary tract symptoms. Grade under 20 in International Prostate Scoring System (IPSS) grading system (mild to severe symptoms). Diagnosis of Benign prostatic hyperplasia(BPH) for the first time through examination Exclusion. Men with BPH, who were candidate surgery Progression of signs and symptoms in the beginning of the study. Diagnosis of the cases such as prostate cance which might have similar symptoms to BPH.
Intervention groups
The patients were divided into two groups of placebo recipient and drug recipient. A white box marked with an "A" was given to the drug recipient group and a similar white box marked with a "B" was given to the placebo recipient group.
Main outcome variables
Investigating the effect of hydroalcoholic extract of Sanjad on the amount of prostate specific antigen Investigating the effect of Sanjad hydroalcoholic extract on the average oxidase factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150622022869N10
Registration date: 2022-11-21, 1401/08/30
Registration timing: registered_while_recruiting

Last update: 2022-11-21, 1401/08/30
Update count: 0
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-30, 1401/08/08
Expected recruitment end date
2022-11-29, 1401/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of hydroalcoholic extract of Elaeagnus angustifolia on oxidative stress and inflammatory markers in patients with mild to moderate Benign Prostatic Hyperplasia
Public title
Evaluation of the effect of hydroalcoholic extract of Elaeagnus angustifolia on oxidative stress and inflammatory markers in patients with mild to moderate Benign Prostatic Hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Men over 45 years old • Presence of lower urinary tract symptoms, including frequent urination, feeling of incomplete emptying, intermittency, feeling of need for urgent emptying, weak and trickling urinary stream, urinary straining, and nocturia; • Grade under 20 in IPSS grading system (mild to severe symptoms); • Diagnosis of BPH for the first time through examination, ultrasonography and related tests.
Exclusion criteria:
• Men with BPS, who were candidate or being candidate at onset of the study; Diagnosing the symptoms of prostate cancer, prostate and gallstones, which sometimes have symptoms similar to BPH.
Age
From 45 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual computer softwares To implement allocation concealment, sequentially numbered opaque sealed envelopes were used. Blinding for patients and researchers
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding was done in a double-blind manner for the patients and the person responsible for collecting the questionnaire, who had the task of evaluating the results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee ofYasuj University of Medical Sciences
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences., Yasuj., Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
IR.YUMS.REC.1401.086

Health conditions studied

1

Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Oxidation factors
Timepoint
At the beginning of the study and 30 days later
Method of measurement
In both groups, Oxidation factors are measured by spectrophotometric method according to the instructions of the kit after one month of consumption.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 500 mg of hydroalcoholic extract of senjed fruit and kernel once a day for 30 days.
Category
Treatment - Drugs

2

Description
Control group: 500 mg of white wheat flour daily for 30 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Muftah Clinic
Full name of responsible person
Moslem Sedaghattalab
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yums.ac.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Sayed Amin Hosseini Motlagh
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghttalab
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghttalab
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghttalab
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the laboratory analysis, the blood samples of the patients are provided in the form of a code along with the age of the patients after distorting the names of the patients.
When the data will become available and for how long
After printing the article
To whom data/document is available
this is available for people working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
Any analysis on the data will be allowed
From where data/document is obtainable
m.sedaghattalab@yuma.ac.com
What processes are involved for a request to access data/document
After sending the email, the required data will be available for up to 1 month
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