Protocol summary
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Study aim
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The aim of the present study was to investigate the effect of nettle extract on insulin resistance, sex hormones and biomarkers of oxidative stress and inflammation in patients with Benign Prostate Hyperplasia.
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Design
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This study is a double blind clinical trial study.This study also has a control group that receives a placebo. Random assignment was done by the use of computer-generated random numbers.
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Settings and conduct
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In the study 60 patients with BPH among males of eligible and referred to Velayat hospital affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, will be selected. Patients and researchers are blind until the end of the study.
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Participants/Inclusion and exclusion criteria
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In this study, men aged 50 to 80, with Benign Prostate Hyperplasia will be included. Unwillingness to cooperate, diabetes, hyper and hypothyroidism, and so anticoagulant use will be excluded.
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Intervention groups
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Patients will be assigned to receive either Stinging Nettle (Urtica dioica L.) extract (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Insulin resistance, sexual hormones and oxidative stress and inflammatory biomarkers in patients with Benign Prostate Hyperplasia will be measured before and after of the intervention.
General information
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Reason for update
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Four outcomes that were not recorded by mistake at the time of initial registration were recorded
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Acronym
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BPH
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IRCT registration information
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IRCT registration number:
IRCT20170430033730N4
Registration date:
2018-07-27, 1397/05/05
Registration timing:
registered_while_recruiting
Last update:
2019-12-01, 1398/09/10
Update count:
1
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Registration date
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2018-07-27, 1397/05/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-26, 1397/03/05
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Expected recruitment end date
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2018-08-25, 1397/06/03
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Stinging Nettle (Urtica dioica L.) extract on insulin resistance, sexual hormones and oxidative stress and inflammatory biomarkers in patients with in patients with Benign Prostate Hyperplasia
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Public title
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Effect of Stinging Nettle (Urtica dioica L.) extract in patients with Benign Prostate Hyperplasia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with benign prostatic hyperplasia
Exclusion criteria:
Patients who use anticoagulant
Diabetic patients
Patients with hypo and/or hyperthyroidism
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Age
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From 50 years old to 80 years old
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Gender
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Male
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization, Random assignment was done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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A placebo was used to blind. Researchers and Patients will be blinded by the professional analyst until final analysis.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-22, 1396/11/02
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Ethics committee reference number
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IR.QUMS.REC.1396.396
Health conditions studied
1
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Description of health condition studied
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Benign Prostate Hyperplasia
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ICD-10 code
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N40
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ICD-10 code description
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Enlarged prostate
Primary outcomes
1
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Description
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International Prostate Symptom Score (I-PSS)
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Standard questionnaire
2
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Description
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Insulin
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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calculation based on standard formula
Secondary outcomes
1
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Description
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Glutathion
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
2
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Description
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MDA
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
3
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Description
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hs-CRP
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
4
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Description
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Testosterone
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
5
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Description
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DHT
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
6
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Description
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Estradiole
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
7
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Description
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Angiopoitin-2
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
8
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Description
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superoxide dismutase
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Omentin
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
10
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Description
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PSA
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: Three pills of nettle extract of 150 mg three times a day for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Three pills of Placebo of 150 mg three times a day for 12 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable