Determining the effect of hydroalcoholic extract of Elaeagnus angustifolia on mild to moderate symptoms of benign prostatic hyperplasia
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 is performed on 96 patients by limited randomization method and with the help of random allocation law.
Settings and conduct
This study is performed in the urology clinic of Yasuj city. In this patient, first, in a room away from the treating physician, the researcher visits, then the patient is visited by a urologist and the drug that the urologist is aware of is given to the patient and the patient's details and the type of drug given on paper Written and placed in a sealed envelope.
Participants/Inclusion and exclusion criteria
All men over 40 years with a definite diagnosis of benign prostatic hyperplasia with an IPSS score below 21
Intervention groups
In the intervention group, they receive one capsule each night, containing 600 mg of hydroalcoholic extract of Elaeagnus angustifolia for 30 days, and in the control group, the same amount of wheat flour is found.
Main outcome variables
The effect of the drug on the excitatory and obstructive symptoms of benign prostatic hyperplasia compared with placebo
General information
Reason for update
Acronym
BPH
IRCT registration information
IRCT registration number:IRCT20150622022869N8
Registration date:2021-11-01, 1400/08/10
Registration timing:registered_while_recruiting
Last update:2021-11-01, 1400/08/10
Update count:0
Registration date
2021-11-01, 1400/08/10
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
2021-10-29, 1400/08/07
Expected recruitment end date
2021-11-13, 1400/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Elaeagnus angustifolia in patients with mild to moderate Benign Prostatic Hyperplasia symptom
Public title
Evaluation of the effect of Elaeagnus angustifolia in patients with mild to moderate Benign Prostatic Hyperplasia symptom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with a diagnosis of benign prostatic hyperplasia with an IPSS score below 21
Exclusion criteria:
Patients with a diagnosis of BPH with an IPSS score above 21
Age
From 40 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Sequencing by randomization with the help of the law of random allocation in such a way that 96 samples, including 48 drugs and 48 placebo, were placed in the drug bag and randomly taken out and given to patients for concealment. Random allocation is used by the non-transparent stamped envelope method, in which the contents of the letter are written by urologist and coded to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher And charge of data collection and the patient in this study is blind and the clinical caregiver who is a urologist is aware of the drugs.
Placebo
Used
Assignment
Parallel
Other design features
This is the first study of bph in humans.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Blood Transfusion Street, Yasouj University of Medical Sciences Campus
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591739308
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.YUMS.REC.1399.095
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
IPSS (International prostate symptom score)questionnaire score
Timepoint
At the beginning of the study and 30 dimensions, the IPSS (International prostate symptom score)questionnaire is filled out for patients (at the same time as the end of the capsules)
Method of measurement
IPSS (International prostate symptom score)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsules containing 600 mg of hydroalcoholic extract of Elm fruit, which is extracted at Yasouj University of Medical Sciences and entered into the capsule, is given to the patient every day for 30 days.
Category
Treatment - Drugs
2
Description
Control group: Wheat flour in the amount of 600 mg in capsules has entered the capsules in the University of Medical Sciences. For 30 days, 1 capsule is given to patients daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj Urology Clinic
Full name of responsible person
Moslem Sedaghattalab
Street address
No. 49, Abuzar 15, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
9999999999
Phone
+98 74 3334 5876
Fax
Email
M.sedaghattalab@yums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj city, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yums.ac.ir
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
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
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 49, Abuzar 15, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
999999999
Phone
+98 74 3322 0163
Fax
+98 74 3322 0163
Email
m.sedaghattalab@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 49, Abuzar 15, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
999999999
Phone
+98 74 3322 0163
Fax
+98 74 3322 0163
Email
m.sedaghattalab@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 49, Abuzar 15, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
9999999999
Phone
+98 74 3322 0163
Fax
+98 74 3322 0163
Email
m.sedaghattalab@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The full study report will be provided to the researchers as a dissertation. Also, the data will be provided to the researchers by deleting personal information.
When the data will become available and for how long
This study will be available to the researcher from the beginning of 1401 AH onwards.
To whom data/document is available
All people who need this data to read more.
Under which criteria data/document could be used
Data are available for analyzes such as meta-analysis studies as well as review studies.
From where data/document is obtainable
m.sedaghttalab@yums.ac.ir
What processes are involved for a request to access data/document
After sending the email, the data will reach the researcher in less than a month.