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IRCT20110427006318N14 IRCT 2020-10-22 Semnan University of Medical Sciences The effect of Curcuma Longa on the chest pain, sleep quality and hemodynamic indices in patients with acute coronary syndrome The effect of Curcuma Longa on the chest pain, sleep quality and hemodynamic indices in patients with acute coronary syndrome 2020-10-24 anticipated 10 Complete https://irct.ir/trial/51220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The research sample assigned to the groups of the study by permuted blocks randomization. The blocks will be (ABC, ACB, BAC, BCA, CAB, CBA), A is the intervention group, B is the control group 1 and C is the control group 2. After randomly selecting one of the six possible blocks, three consecutive samples are randomly placed in one of the groups (intervention, control 1 or control 2). Blocking is used within sex, randomization is done separately for men and women, Blinding description: The medicine is given to the patient by the physician, so that the researcher and the patients participating in the study do not know about the type of intervention (Curcuma Longa, control 1 or control 2) and do not know who is in which group (double blind). 3 Acute coronary syndrome. Intervention 1: Intervention group: The intervention group received one 500 mg Curcuma Longa tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen. Intervention 2: Control group: The control group 1 receives placebo tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen. Intervention 3: Control group: The control group 2 receives routine regimen. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data is confidential
public Monir Nobahar
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@semums.ac.ir Semnan University of Medical Sciences scientific Monir Nobahar
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Diagnosis acute coronary syndrome Patient consent for participation in the study Patient 45 to 75 years old Lack of active mental illness, mental retardation, deafness, blindness Lack of sensitivity to Curcuma Longa Lack of addiction to alcohol and Opioid Patients who are able to speak and understand language and conscious No history of sleeping drugs consumption Chest pain score greater than four Systolic blood pressure 90-100 mmHg 45 years 75 years Both Pregnant women Patients with gallstones or bile disorders Treatment - Other Placebo Other Intervention group: The intervention group received one 500 mg Curcuma Longa tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen. Control group: The control group 1 receives placebo tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen. Control group: The control group 2 receives routine regimen. Chest pain. Timepoint: Evaluation of pain is performed before and half an hour after the intervention for three consecutive days. Method of measurement: Numeric Rating Scale. Sleep quality. Timepoint: Evaluation of sleep quality is performed before the intervention and three consecutive days. Method of measurement: St Mary's Hospital Sleep Questionnaires. Hemodynamic indicators. Timepoint: Evaluation of hemodynamic parameters is performed before and half an hour after the intervention for three consecutive days. Method of measurement: Monitor of Pooyandegan Rah-e-Salamat. Semnan University of Medical Sciences Approved 2020-09-22 Ethics committee of Semnan University of Medical science Semnan University of Medical Sciences, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)