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IRCT20201129049534N4 IRCT 2021-07-13 The effects of curcumin-piperne supplementation on CABG patient 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 2021-08-19 anticipated 80 Complete https://irct.ir/trial/56930 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Cardiovascular disease. Intervention 1: Intervention group 1:Patients who receive three capsules containing 500 mg of curcumin and 5 mg of piperine per day for 5 days. Intervention 2: 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. Intervention 3: 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. Intervention 4: Control group: Patients receiving 3 placebo capsules for 5 days, each capsule containing 500 mg of maltodextrin per day. Yes - There is a plan to make this available What will be shared: Study information will be published after the individuals are unidentified and after the project is completed. When: Access period starts six months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided. Comments:
public Mohammad Bagherniya
Hezar-jerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3972 3138 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 30 years 80 years Both 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 I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1:Patients who receive three capsules containing 500 mg of curcumin and 5 mg of piperine per day for 5 days 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 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 Control group: Patients receiving 3 placebo capsules for 5 days, each capsule containing 500 mg of maltodextrin per day C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Blood urea nitrogen (BUN). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Creatinine (Cr). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Lactate Dehydrogenase (LDH). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. CK-MB. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. Troponin. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. 28-days mortality rate. Timepoint: End of the study. Method of measurement: Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up. Atrial fibrillation. Timepoint: End of the study. Method of measurement: Electrocardiogram (ECG or EKG). Approved 2021-06-23 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)