The exploring the Effect of nettle extract on decreasing urinary problems and prostate size in elderly with benign prostatic hyperplasia
Design
A randomized controlled clinical trial with parallel groups, three blinded, randomized
Settings and conduct
Patients referred to the urology clinic with definitive diagnosis of benign prostatic hyperplasia are divided into two groups of experimental and control. Samples were divided into control (n = 40) and experimental (n = 40) groups. Urinary Tract Questionnaire will be used to measure urinary problems. Both groups will then receive routine medical and nursing treatments, but the patients in the experimental group will receive 300 mg twice daily oral capsule in addition to routine nursing interventions after 8 weeks. Weekly urinary problems (check list) and prostate volume (via ultrasound) will be assessed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Elderly over 60 years with BPH diagnosis
• No urinary tract infection or bladder stones
• Patients in the BPH drug phase
Exclusion criteria
• Willingness not to continue cooperation
• Any drug-induced allergic side effects
Intervention groups
Both groups will receive regular medical and nursing treatments, but patients in the test group will receive 300 mg of nettle root extract twice a day, in the form of oral capsules, for 8 weeks in addition to receiving routine nursing interventions.
Main outcome variables
The variable is the main consequence of the size of the prostate gland. Before and after consuming the extract of nettle root, it would examined by test and ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100124003146N9
Registration date:2020-04-12, 1399/01/24
Registration timing:prospective
Last update:2020-04-12, 1399/01/24
Update count:0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Ismail Azizi-Fini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
azizi-es@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The exploring the Effect of nettle extract on decreasing urinary problems and prostate size in elderly with benign prostatic hyperplasia
Public title
The exploring the Effect of nettle extract on decreasing urinary problems and prostate size in elderly with benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly with benign prostatic hypertrophy
No urinary tract infection or bladder stones
No history of allergy to dark mint plants such as nettle
Exclusion criteria:
refuse to continue cooperation
The occurrence of any drug-induced allergic side effects
Age
From 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria will be randomly divided into intervention and control groups by block randomization (Blocks with size 4).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Only researchers will know the contents of packages. The prescriber, who is a co-physician with the plan, will not know if the package contains the nettle capsule or placebo (starch). Packages will be marked with code. Patients will also be unaware of the contents of the packages in order not to switch medications. Patients will be told not to consume nettle plant products during the course of the plan. Also, the statistical analyst will not know the test and control groups in order to avoid bias in the analysis of results. So this study will be three-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th kilometer Qotb Ravandi blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.072
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
Prostate size
Timepoint
8 weeks
Method of measurement
Specific antigen prostate test and prostate sonography and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will receive 300 mg of nettle root extract twice daily for 8 weeks in addition to the usual nursing interventions. After 8 weeks, urinary problems (by checklist) and prostate volume (by ultrasound) will be checked again.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive placebo twice daily for 8 weeks in addition to usual placebo nursing interventions. After 8 weeks, urinary problems (by checklist) and prostate volume (by ultrasound) will be checked again.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital of Kashan
Full name of responsible person
Dr. Hossein Mahmoudi
Street address
Kashan University of Medical Sciences, Faculty of Nursing and Midwifery
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
msaeidm63@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
5th kilometer Qotb Ravandi Blouvar.Parastar blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
msaeidm63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr Esmail Azizi-Fini
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5Th Kilometer Qotb Ravandi blouvar.kashan university of medical sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizi-es@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Esmail Azizi-Fini
Position
َassisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5th kilometer Qotb Ravandi Blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizi-es@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Esmail Aziz-Fini
Position
َassisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5th kilometer Qotb Ravandi Blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizi-es@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Yes - There is 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 results related to the main outcome will be distributed.
When the data will become available and for how long
after the publication of the article
To whom data/document is available
all people
Under which criteria data/document could be used
data will be confidential
From where data/document is obtainable
aziz-es@kaums.ac.ir
What processes are involved for a request to access data/document