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IRCT20180413039292N1 IRCT 2018-04-27 Islamic Azad University The Effect of Valeriana 0fficinalis (Valerian) on Sleep Quality and Fatigue of Patients with Chronic Obstructive Pulmonary Disease The Effect of Valeriana 0fficinalis (Valerian) Oral Extract on Sleep Quality and Fatigue of Patients with Chronic Obstructive Pulmonary Disease 2018-04-29 anticipated 60 Complete https://irct.ir/trial/30762 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples are firstly selected through available sampling from those referring to the criteria for entering the research. In order to ensure that the conditions of the study and to avoid bias in the face of the interventional conditions, the random allocation method will be used for placement of patients in the control and test groups. To do this, a list of all patients with chronic obstructive pulmonary disease referring to the educational hospitals of the Islamic Azad University of Medical Sciences that have criteria for entering the study is provided and numbered to each patient. Then they will be randomly selected using the random sample table and will be randomly assigned to two groups, Blinding description: The study will be triple-blind so that the packaging of capsules, one shape, and capsules A and B will be packaged by the pharmacist. The capsules of the two groups are united in similar formulations. Medicines without a name are prescribed by the code and the findings will be recorded in a separate form. The researcher will not be informed about the samples as well as analyzing the statistical information about the contents of the capsules, and only the pharmacist will inform the group upon completion of the statistical analysis of the content of the capsules. Therefore, the present study will be carried out in triple succor. 3 Patients with Chronic Obstructive Pulmonary Disease. Intervention 1: Intervention group: Oral capsule of Valerian extract containing 300 mg of the root of the plant for four weeks, once a day (one hour before bedtime). Intervention 2: Control group: Oral capsule containing starch 50 mg for four weeks, once a day (one hour before bedtime). 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 I have not decided yet - its release plan is still unclear
public Samaneh Shahabi
No 1, Blind Alley Ashenavar, Alley Ataii, Hashemi Street, Ostad Modin Boulevard
Tehran Iran (Islamic Republic of) 1349837793 +98 21 6605 1482 samanehshahabi@ymail.com Islamic Azad University scientific Zohreh Parsa Yekta
Islamic Azad University Medical Sciences of Tehran, Khaghani street, Shariati Street
Tehran Iran (Islamic Republic of) 1916893813 +98 21220066607 zparsa@tums.ac.ir Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of chronic obstructive pulmonary disease in stage one and two diseases, based on medical history and clinical symptoms and patient records Having some degree of fatigue, according to the Fatigue Severity Index (MFI), the total score obtained from fatigue in patients between 20 to 100 can be. The higher the score, the higher the fatigue Earn more than 6 points in response to Pittsburgh Sleep Quality Index Stable patient clinical condition (no acute problems) and no other chronic disease Aged 18 years and older Ability to read and write Persian texts Both sexes, both male and female Do not use other herbs during the intervention Not having a history of eczema and allergies to plants Complete vigilance Not having drug and alcohol addiction Not taking patients from benzodiazepines, sedative drugs, sleep deprivation and opiate during intervention Not Pregnant women of childbearing age 18 years no limit Both The occurrence of any physical and mental illness during the study that causes sleep disorder Existence of any significant changes in sleep conditions in an unpredictable way, including travel, change of location and ... Do not take capsules for up to 7 days during a month The patient's personal desire to quit for any reason Early diagnosis of obstructive apnea J41.1 Mucopurulent chronic bronchitis Rehabilitation Placebo Intervention group: Oral capsule of Valerian extract containing 300 mg of the root of the plant for four weeks, once a day (one hour before bedtime) Control group: Oral capsule containing starch 50 mg for four weeks, once a day (one hour before bedtime) Fatigue score in MFI fatigue questionnaire, sleep quality score in Pittsburgh questionnaire. Timepoint: Fatigue measurements were performed by the MFI fatigue and sleep quality questionnaire by Pittsburgh questionnaire before the intervention, after 2 weeks of the intervention and again at the end of week 4 after taking valerian. Method of measurement: MFI Fatigue Inventory, Pittsburgh Sleep Quality Questionnaire. Islamic Azad university Approved 2017-07-25 Ethics committee of Islamic Azad University, Tehran Medical Sciences Unit 1 and 2, No 1, Akhavar Blvd Alley, Ataei Alley, Hashemi Avenue, Moein Shaheedeh Blve Tehran Tehran Iran (Islamic Republic of)