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IRCT20171216037895N2 IRCT 2019-05-18 Esfahan University of Medical Sciences The effect of matricaria recutita on the quality of sleep The effect of matricaria recutita drop on sleep quality in patients with choronic heart failure hospitialized 2018-07-23 anticipated 70 Complete https://irct.ir/trial/39195 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Peoples who have inclusion criteria will be randomly assigned into two groups of intervention and control. In this way, 35 cards with number one and 35 cards with number two are enclosed in an envelope, and they are asked to select a card on the day of the random division of the research units. People with number are located in test group, and those with number two are included in control group, Blinding description: To eliminate individual factors in the results, the study is done as triple blind. Thus, the samples do not know in which group they are located. Furthermore, two collaborators are hired to do the sampling. In this way, collaborators provide the samples with the medicine and questionnaire. The statistician is not aware of the treatment groups. 3 Condition 1: Sleep disorders. Condition 2: Chronic heart failure. Intervention 1: Intervention group: The intervention receives chamomile drops, called chamazulene (containing a complete extract of chamomile), at 30 drops (about 2 cc), manufactured by Sina Farouor Pharmaceutical Company in Isfahan, in half a glass of water plus half a cube of sugar under the supervision of a doctor before bedtime at midnight in the cardiology department of the hospital for one week. Intervention 2: Control group: In this group, patients are followed up for one week by a doctor. In the same way as a test group, they receive a placebo or a prescriber at the same hour before bedtime. The placebo contains 1.0 cc of the main medicine. This means that there is 1 cc of the main medicine in 10 cc of hydrochemical solution. Moreover, the placebo in terms of color, odor, appearance, and packaging is not different from the original medicine. However, it can be distinguished from the original medicine by the code. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Shahram Rashidi
Isfahan University of Medical Sciences, Street Hezarjarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 2918 shahramrashidiesf@gmail.com Esfahan University of Medical Sciences scientific Dr Sima Babaee
Isfahan University of Medical Sciences., Hezarjarib St
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 2918 babaee@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Being aware of time and place The absence of neurological and psychiatric diseases mentioned in the medical history of the patient Age 40 to 67 years old Familiar with Farsi Mild to moderate heart failure Ejection fraction between 20 to 40% Different degrees of sleep disorders include insomnia, delayed sleep, sleep deprivation, sleep disturbance, and overall sleep quality score of over 12, based on St. Mary's Hospital Sleep Quality Questionnaire Not having a physical illness affecting sleep, such as asthma and thyroid disorders Do not use drugs that affect sleep such as sedation, housing, antidepressants No smoking and alcohol Not having any sensitivity to chamomile and its compounds by means of a questionnaire through a demographic questionnaire on the absence of nausea and vomiting and skin rash following the use of its compounds Not having sleep apnea Failure to develop restless leg syndrome Lack of severe pain and sleep discomfort Not using complementary medicine in a recent week Stability of vital signs 40 years 67 years Both History of heart attack three months ago Significant arrhythmia G47 I50 Sleep disorders Heart failure Treatment - Drugs Placebo Intervention group: The intervention receives chamomile drops, called chamazulene (containing a complete extract of chamomile), at 30 drops (about 2 cc), manufactured by Sina Farouor Pharmaceutical Company in Isfahan, in half a glass of water plus half a cube of sugar under the supervision of a doctor before bedtime at midnight in the cardiology department of the hospital for one week. Control group: In this group, patients are followed up for one week by a doctor. In the same way as a test group, they receive a placebo or a prescriber at the same hour before bedtime. The placebo contains 1.0 cc of the main medicine. This means that there is 1 cc of the main medicine in 10 cc of hydrochemical solution. Moreover, the placebo in terms of color, odor, appearance, and packaging is not different from the original medicine. However, it can be distinguished from the original medicine by the code. Sleep quality. Timepoint: Before the intervention, three days and a week after the intervention. Method of measurement: St. Mary's Hospital Sleep Quality Questionnaire. Esfahan University of Medical Sciences Approved 2018-07-15 Ethics Committee of the Isfahan University of Medical Sciences Isfahan University of Medical Sciences., Street Hezarjarib Isfahan Isfehan Iran (Islamic Republic of)