Study of the effect of curcumin on insulin resistance, sexual hormones and oxidative stress and inflammatory biomarkers in patients with Benign Prostate Hyperplasia
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
The aim of the present study was to investigate the effect of curcumin on insulin resistance, sex hormones and biomarkers of oxidative stress and inflammation in patients with Benign Prostate Hyperplasia.
The aim of the present study was to investigate the effect of curcumin on insulin, sex hormones and biomarkers of oxidative stress and inflammation in patients with Benign Prostate Hyperplasia.
The aim of the present study was to investigate the effect of curcumin on insulin resistance, sex hormones and biomarkers of oxidative stress and inflammation in patients with Benign Prostate Hyperplasia.
هدف مطالعه حاضر بررسی اثر کورکومین بر مقاومت انسولین، هورمونهای جنسی و بیومارکرهای استرس اکسیداتیو و التهابی در بیماران مبتلا به هایپرپلازی خوش خیم پروستات می باشد
هدف مطالعه حاضر بررسی اثر کورکومین بر انسولین، هورمونهای جنسی و بیومارکرهای استرس اکسیداتیو و التهابی در بیماران مبتلا به هایپرپلازی خوش خیم پروستات می باشد
هدف مطالعه حاضر بررسی اثر کورکومین بر مقاومت انسولین، هورمونهای جنسی و بیومارکرهای استرس اکسیداتیو و التهابی در بیماران مبتلا به هایپرپلازی خوش خیم پروستات می باشد
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.
Insulin , sexual hormones and oxidative stress and inflammatory biomarkers in patients with Benign Prostate Hyperplasia will be measured before and after of the intervention.
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.
مقاومت انسولین، هورمونهای جنسی و بیومارکرهای استرس اکسیداتیو و التهابی در بیماران مبتلا به هایپرپلازی خوش خیم پروستات قبل و بعد از مداخله اندازه گیری خواهد شد.
انسولین، هورمونهای جنسی و بیومارکرهای استرس اکسیداتیو و التهابی در بیماران مبتلا به هایپرپلازی خوش خیم پروستات قبل و بعد از مداخله اندازه گیری خواهد شد.
مقاومت انسولین، هورمونهای جنسی و بیومارکرهای استرس اکسیداتیو و التهابی در بیماران مبتلا به هایپرپلازی خوش خیم پروستات قبل و بعد از مداخله اندازه گیری خواهد شد.
General information
empty
one outcome that was not recorded by mistake at the time of initial registration, was recorded
one outcome that was not recorded by mistake at the time of initial registration, was recorded
empty
یک پیامد که در زمان ثبت اولیه به اشتباه ثبت نشده بود، تبت شد
یک پیامد که در زمان ثبت اولیه به اشتباه ثبت نشده بود، تبت شد
Primary outcomes
#1
FBS
International Prostate Symptom Score (IPSS)
FBSInternational Prostate Symptom Score (IPSS)
قند خون ناشتا
نشانگر بین المللی علائم پروستات
قند خون ناشتانشانگر بین المللی علائم پروستات
Spectrophotometry
Standard questionnaire for International Prostate Symptom Score evaluation
SpectrophotometryStandard questionnaire for International Prostate Symptom Score evaluation
اسپکتروفوتومتری
پرسشنامه استاندارد برای ارزیابی نشانگر بین المللی علائم پروستات
اسپکتروفوتومتریپرسشنامه استاندارد برای ارزیابی نشانگر بین المللی علائم پروستات
Protocol summary
Study aim
The aim of the present study was to investigate the effect of curcumin on insulin, sex hormones and biomarkers of oxidative stress and inflammation in patients with Benign Prostate Hyperplasia.
Design
Random assignment was done by the use of computer-generated random numbers. Population and sample size: 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.
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: In this study, men aged 50 to 80, with Benign Prostate Hyperplasia will be included. Exclusion criteria: unwillingness to cooperate, diabetes, hyper and hypothyroidism, and so anticoagulant use will be excluded.
Intervention groups
Patients will be assigned to receive either curcumin (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Insulin , 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
one outcome that was not recorded by mistake at the time of initial registration, was recorded
Acronym
IRCT registration information
IRCT registration number:IRCT20170430033730N3
Registration date:2018-07-08, 1397/04/17
Registration timing:retrospective
Last update:2020-06-09, 1399/03/20
Update count:1
Registration date
2018-07-08, 1397/04/17
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
2018-05-27, 1397/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of curcumin on insulin resistance, sexual hormones and oxidative stress and inflammatory biomarkers in patients with Benign Prostate Hyperplasia
Public title
Study of effect of curcumin in patients with Benign Prostate Hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with benign prostatic hyperplasia
Exclusion criteria:
patients who do not want to cooperate
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
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.1396.408
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 (IPSS)
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Standard questionnaire for International Prostate Symptom Score evaluation
2
Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
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
Intervention groups
1
Description
Intervention group: Two capsules of 80 mg of curcumin were taken twice daily for twelve weeks
Category
Treatment - Drugs
2
Description
Control group: Two capsules of 80 mg of placebo are given twice 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 28 3333 6001
Fax
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 Beheshti Blvd - Valiasr Square
City
Qazvin
Province
Qazvin
Postal code
34156-13911
Phone
+98 28 3333 7006
Email
a.peymani@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