Protocol summary
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Study aim
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The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indicators in patients with ischemic stroke in the rehabilitation phase: a double-blind clinical trial study
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Design
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Randomized, double-blind, placebo-controlled clinical trial
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Settings and conduct
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In this study, 60 patients with a stroke referred to the Imam Moosa Sadr Clinic were randomly divided into intervention (Curcumin-piperine 500 mg) and placebo (maltodextrin) according to inclusion and exclusion criteria. , so the researcher did not know the intervention type in addition to the participants themselves. To double-blind this study, all capsules were coded as A and B prior to study initiation, so that the researcher did not know the intervention type addition to the participants themselves.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: The person has had a stroke only once, At least 3-6 months have passed since the stroke (sub acute and chronic phase), NIHSS =5-24, diagnosis of stroke by CT-scan and MRI, Age=20-65 years old, BMI=18/5-35, Tendency to participate in the study. Exclusion criteria: Taking anticoagulants such as aspirin, heparin, warfarin, etc. Taking antioxidant and multivitamin supplements and omega-3 supplements.Having malignant diseases and cancers
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Intervention groups
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Intervention group a daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) and placebo group a daily maltodextrin capsule will receive after meal for 12 weeks.
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Main outcome variables
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TG; TC; HDL; LDL; Weight; BMI; Waist circumference; Total antioxidant capacity; Fibrinogen; Hs-CRP; BP
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N48
Registration date:
2020-12-18, 1399/09/28
Registration timing:
prospective
Last update:
2023-01-11, 1401/10/21
Update count:
1
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Registration date
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2020-12-18, 1399/09/28
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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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2020-12-19, 1399/09/29
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Expected recruitment end date
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2021-04-18, 1400/01/29
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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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The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indicators in patients with ischemic stroke in the rehabilitation phase: a double-blind clinical trial study
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Public title
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Effect of curcumin-piperine in patients with ischemic stroke
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The person has had a stroke only once
At least 3-6 months have passed since the stroke (subacute and chronic phase)
NIHSS =5-24
diagnosis of stroke by CT-scan and MRI
Age=20-65 years old
BMI=18/5-35
Tendency to participate in the study
Exclusion criteria:
Taking anticoagulants such as aspirin, heparin, warfarin, etc.
Taking antioxidant and multivitamin supplements and omega-3 supplements
Having malignant diseases and cancers
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random number table
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In order to conduct this research in a double-blind manner, before starting the study, the relevant capsules are coded in A and B by a person other than the researcher, so that the researcher does not know the type of capsules received by both participants and researchers.
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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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2020-11-18, 1399/08/28
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1399.593
Health conditions studied
1
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Description of health condition studied
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Ischemic stroke
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ICD-10 code
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I63
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ICD-10 code description
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Cerebral infarction
Primary outcomes
1
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Description
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HS-CRP
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Timepoint
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The beginning and the end of the study
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Method of measurement
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ELISA kit
2
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Description
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TAC
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Laboratory method
3
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Description
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Fibrinogen plasma level
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Timepoint
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The beginning and the end of the study
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Method of measurement
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ELISA kit
4
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Description
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Lipid profile
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Enzymatic method
5
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Description
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Systolic and diastolic blood pressure
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Mercury Barometer
Secondary outcomes
1
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Description
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Weight
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Digital scale
2
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Description
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Waist Circumference (WC)
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Inelastic meters
3
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Description
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Body mass index (BMI)
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Dividing the weight into kilograms by squared height by meter
Intervention groups
1
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Description
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Intervention group: A daily curcumin-piperine capsule(500 mg curcumin + 5 mg piperine) will receive after meal 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: A daily placebo capsule(505 mg maltodextrin) will receive after meal for 12 weeks
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Category
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Placebo
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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Esfahan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The collected deidentified for the primary outcome measure only will be shared
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Researchers and academic and research institutes
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Under which criteria data/document could be used
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To do similar designs
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From where data/document is obtainable
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Answer the person
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What processes are involved for a request to access data/document
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The data will be sent to the person after receiving the request and reviewing the request.
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Comments
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