Protocol summary
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Study aim
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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.
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Design
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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.
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Patients will be assigned to receive either curcumin (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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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
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Reason for update
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one outcome that was not recorded by mistake at the time of initial registration, was recorded
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Acronym
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IRCT registration information
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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
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Registration date
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2018-07-08, 1397/04/17
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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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2018-05-27, 1397/03/06
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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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Study of the effect of curcumin on insulin resistance, sexual hormones and oxidative stress and inflammatory biomarkers in patients with Benign Prostate Hyperplasia
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Public title
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Study of effect of curcumin 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 do not want to cooperate
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
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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.1396.408
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 (IPSS)
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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 for International Prostate Symptom Score evaluation
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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ELISA
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
Intervention groups
1
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Description
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Intervention group: Two capsules of 80 mg of curcumin were taken twice daily for twelve weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Two capsules of 80 mg of placebo are given twice 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