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IRCT20201123049474N1 IRCT 2020-11-27 Esfahan University of Medical Sciences The effect of ginger and cinnamon on chemotherapy induced nausea and vomiting The effect of ginger and cinnamon in comparison with control group, on chemotherapy induced nausea and vomiting with high emetic drugs in cancer patients 2020-12-20 anticipated 144 Complete https://irct.ir/trial/52519 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done with a simple random method and creating random values ​​between zero and one in spss software. In order to determine random values ​​to the intervention or control group, less than or equal to 0.5 values ​​are assigned to group A and values ​​greater than 0.5 to group B. The pharmacotherapist then encodes 144 packages (based on the codes obtained in the above randomization method) and determines the list of codes. Inside each package, according to the above method, intervention medicine or placebo will be placed and in order of eligible patients entering the clinic, will be given to the patients and the method of taking the drugs will be explained to the patients by oncologist. Package codes are written on each patient's questionnaire, Blinding description: Drugs and placebo are prepared by pharmacotherapist in similar shapes, colors and weights and are packaged and coded in similar packages in two groups of drugs and placebo so that all people involved in the research are unaware of the main nature of the capsules. After collecting the data, an envelope related to the coding of drug packages and patient information will be provided to the data analyzer. 3 Nausea and vomiting. Intervention 1: Intervention group: Capsules containing 250 mg of Ginger and 250 mg of Cinnamon, which is taken every 6 hours from 3 days before the start of chemotherapy to 3 days after and produced by Amin Pharmaceutical Company. Intervention 2: Control group: Placebo is similar in weight and appearance to the intervention drug produced by Amin Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: 6 months after publication To whom: academic institutions Conditions: Any analysis is allowed Where to obtain: Email address: Mohammad Amin dr.mohamad.amin@gmail.com How to obtain: Send the request and the type of data analysis used to the relevant email for review Comments:
public Mohammad Amin
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
Isfehan Iran (Islamic Republic of) 8174675731 +98 31 3620 1991 Dr.mohamad.amin@gmail.com Esfahan University of Medical Sciences scientific Mohammad Amin
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
Isfehan Iran (Islamic Republic of) 8174675731 +98 31 3620 1991 Dr.mohamad.amin@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years and older Definitive diagnosis of cancer by oncologist and pathologist Receive one-day chemotherapy courses with high emetic risk drugs according to the American Society of Clinical Oncology Guidline Normal hematological and biochemical tests 18 years no limit Both Receiving concurrent radiotherapy with chemotherapy Taking therapeutic doses of warfarin, heparin or aspirin History of hematological disorders (such as severe thrombocytopenia) Gastrointestinal cancer History of allergy to ginger or cinnamon Taking ginger or cinnamon during the last week Having other problems causing nausea such as hypertension, liver or kidney failure and digestive problems R11 Nausea and vomiting Prevention Placebo Intervention group: Capsules containing 250 mg of Ginger and 250 mg of Cinnamon, which is taken every 6 hours from 3 days before the start of chemotherapy to 3 days after and produced by Amin Pharmaceutical Company Control group: Placebo is similar in weight and appearance to the intervention drug produced by Amin Pharmaceutical Company Frequency of nausea and vomiting. Timepoint: 3 days before chemotherapy to 3 days after and every 12 hours at the same time as the intervention. Method of measurement: The Index of Nausea, Vomiting, and Retching questionnaire. Intensity of nausea and vomiting. Timepoint: 3 days before chemotherapy to 3 days after and every 12 hours at the same time as the intervention. Method of measurement: The Index of Nausea, Vomiting, and Retching questionnaire. Esfahan University of Medical Sciences Approved 2020-11-24 Ethics committee of Isfahan medical university Ethics committee of Isfahan medical university, Building No. 4, Isfahan medical university, Hezar Jarib Street Isfehan Isfehan Iran (Islamic Republic of)