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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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History
# Registration date Revision Id
2 2019-11-23, 1398/09/02 112424
1 2018-07-27, 1397/05/05 54164
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  • General information

    empty
    Four outcomes that were not recorded by mistake at the time of initial registration were recorded
    empty
    چهار پیامد که در زمان ثبت اولیه ، به اشتباه ثبت نشده بود، ثبت گردید
    patients who use anticoagulant
    diabetic patients
    patients with hypo and/or hyperthyroidism
    Patients who use anticoagulant
    Diabetic patients
    Patients with hypo and/or hyperthyroidism

  • Primary outcomes

    #1
    FBS
    International Prostate Symptom Score (I-PSS)
    قند خون ناشتا
    اسکور پروستات
    Spectrophotometry
    Standard questionnaire
    اسپکتروفوتومتری
    پرسشنامه استاندارد
    #2
    انسولین
    مقاومت انسواین
    ELISA
    calculation based on standard formula
    الایزا
    محاسبه بر اساس فرمول استاندارد

  • Secondary outcomes

    #1
    empty
    superoxide dismutase
    empty
    سوپراکساید دیسموتاز
    empty
    At the beginning of the study and 12 weeks after the intervention
    empty
    در شروع مطالعه و دوازده هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفوتومتری
    #2
    empty
    Omentin
    empty
    امنتین
    empty
    At the beginning of the study and 12 weeks after the intervention
    empty
    در شروع مطالعه و دوازده هفته بعد از مداخله
    empty
    ELISA
    empty
    الایزا
    #3
    empty
    PSA
    empty
    انتی ژن پروستات
    empty
    At the beginning of the study and 12 weeks after the intervention
    empty
    در شروع مطالعه و دوازده هفته بعد از مداخله
    empty
    ELISA
    empty
    الایزا

Protocol summary

Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Patients will be assigned to receive either Stinging Nettle (Urtica dioica L.) extract (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
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

Reason for update
Four outcomes that were not recorded by mistake at the time of initial registration were recorded
Acronym
BPH
IRCT registration information
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
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Seyyed Mehdi Mirhashemi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
sm.mirhashemi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2018-08-25, 1397/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Stinging Nettle (Urtica dioica L.) extract in patients with Benign Prostate Hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with benign prostatic hyperplasia
Exclusion criteria:
Patients who use anticoagulant Diabetic patients Patients with hypo and/or hyperthyroidism
Age
From 50 years old to 80 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random assignment was done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo was used to blind. Researchers and Patients will be blinded by the professional analyst until final analysis.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-01-22, 1396/11/02
Ethics committee reference number
IR.QUMS.REC.1396.396

Health conditions studied

1

Description of health condition studied
Benign Prostate Hyperplasia
ICD-10 code
N40
ICD-10 code description
Enlarged prostate

Primary outcomes

1

Description
International Prostate Symptom Score (I-PSS)
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Standard questionnaire

2

Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
calculation based on standard formula

Secondary outcomes

1

Description
Glutathion
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

2

Description
MDA
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

3

Description
hs-CRP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

4

Description
Testosterone
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

5

Description
DHT
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

6

Description
Estradiole
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

7

Description
Angiopoitin-2
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

8

Description
superoxide dismutase
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

9

Description
Omentin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

10

Description
PSA
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: Three pills of nettle extract of 150 mg three times a day for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Three pills of Placebo of 150 mg three times a day for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 34 1975 9811
Email
mirhashemism@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peimani
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34156-13911
Phone
+98 28 3333 7006
Email
mirhashemism@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com

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 further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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