Protocol summary
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Study aim
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Determination of the effectiveness of curcumin-piperine supplementation on inflammatory factors, cardiac biomarkers, atrial fibrillation and clinical outcomes after CABG
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Design
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A randomized, double-blind, clinical trial will be performed on 80 people. Randomization is done using a valid website and a 4-block method.
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Settings and conduct
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This clinical trial will be performed in Chamran and Sina hospitals in Isfahan. Curcumin piperine and placebo will be administered in exactly the same packages to the patient. Patients and researchers will not be aware of the type of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Completion of a consent form, age 30 to 80 years, gastrointestinal tract with normal function, ejection fraction above 35%, arrest time 30 to 90 minutes. Exclusion criteria: Sensitivity to herbal products such as turmeric and pepper, Herbal supplementation consumption during 3 months before surgery, need for emergency surgery, need for pump balloon, addition of other surgery, pregnancy and lactation.
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Intervention groups
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Intervention group 1: three capsules, each capsule containing 500 mg of curcumin and 5 mg of piperine per day. Intervention group 2: Two capsules, each capsule containing 500 mg of curcumin and 5 mg of piperine plus one placebo. Intervention group 3: One capsule containing 500 mg of curcumin and 5 mg of piperine plus two placebo capsules. Control group: 3 placebo capsules, each capsule containing 500 mg of maltodextrin per day.
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Main outcome variables
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Inflammatory factors, cardiac biomarkers, and atrial fibrillation. Kidney function tests (BUN, Cr)
General information
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Reason for update
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The type of study changed from a pilot study to a double-blind randomized clinical controlled trial.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201129049534N4
Registration date:
2021-07-13, 1400/04/22
Registration timing:
prospective
Last update:
2022-10-30, 1401/08/08
Update count:
2
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Registration date
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2021-07-13, 1400/04/22
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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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2021-08-19, 1400/05/28
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Expected recruitment end date
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2022-08-19, 1401/05/28
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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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Evaluation of the effectiveness of curcumin-piperine supplementation on inflammatory factors, cardiac biomarkers, atrial fibrillation and clinical outcomes after coronary artery bypass graft surgery (CABG): A randomized double-blind, placebo-controlled, dose–response study
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Public title
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The effects of curcumin-piperne supplementation on CABG patient
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 30-80 years
Gastrointestinal normal function and with intestinal or oral nutrition criteria
Ejection fraction (EF) above 15%
Arrest Time (cardiac resuscitation) 30 to 90 minutes
Willingness to participate in the study and complete the consent form before surgery
Exclusion criteria:
Allergy to herbal products such as turmeric and pepper
Taking herbal supplements (as a supplement) during 3 months before the operation
Need for emergency surgery
Requires balloon pump
Adding another operation in addition to CABG, like simultaneous valve operation
Patients who do not have an indication for intestinal or oral nutrition on the first day of the intervention and are expected to be unable to receive intestinal or oral nutrition in the future
Patients with a history of underlying disease such as congenital and immune disorders and pancreatitis
Pregnancy and lactation
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Age
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From 30 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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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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Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
In this way, people are randomly divided into four groups of intervention and control using quadruple blocks based on age and sex.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For blinding the researchers, curcumin piperine and placebo capsules are purchased from Sami labs Ltd., India similar in shape, color, and size. These capsules are coded by someone other than the researchers (A and B) and the researcher distributes them without knowing the type of capsules. Patients and researchers will not be aware of the type of capsule until the end of the study.
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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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2021-06-23, 1400/04/02
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.135
Health conditions studied
1
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Description of health condition studied
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Cardiovascular disease
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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C reactive Protein (CRP)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
2
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Description
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Blood urea nitrogen (BUN)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
3
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Description
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Creatinine (Cr)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
4
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Description
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Lactate Dehydrogenase (LDH)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
5
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Description
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CK-MB
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Timepoint
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At baseline and end of the study
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Method of measurement
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Commercial diagnostic kit
6
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Description
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Troponin
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Timepoint
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At baseline and end of the study
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Method of measurement
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Commercial diagnostic kit
Secondary outcomes
1
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Description
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28-days mortality rate
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Timepoint
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End of the study
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Method of measurement
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Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up
2
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Description
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Atrial fibrillation
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Timepoint
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End of the study
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Method of measurement
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Electrocardiogram (ECG or EKG)
Intervention groups
1
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Description
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Intervention group 1:Patients who receive three capsules containing 500 mg of curcumin and 5 mg of piperine per day for 5 days
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Patients receiving two capsules containing 500 mg of curcumin and 5 mg of piperine for 5 days plus a placebo containing 500 mg of maltodextrin per day
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: Patients receiving one capsule containing 500 mg curcumin and 5 mg piperine for 5 days plus two placebo tablets containing 500 mg maltodextrin per day
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Category
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Treatment - Drugs
4
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Description
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Control group: Patients receiving 3 placebo capsules for 5 days, each capsule containing 500 mg of maltodextrin per day
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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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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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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study information will be published after the individuals are unidentified and after the project is completed.
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When the data will become available and for how long
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Access period starts six months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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For further analysis
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From where data/document is obtainable
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Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir
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What processes are involved for a request to access data/document
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After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.
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Comments
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