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IRCT20150919024080N15 IRCT 2020-03-03 Khoram-Abad University of Medical Sciences The effect of Ocimum on sleep and cognitive function The effect of Ocimum Hydro Alcoholic Extract on Cognitive Function and Sleep Quality in patients with Choronic Obstructive Pulmonary Disease: A randomized controlled clinical trial 2019-12-22 anticipated 96 Complete https://irct.ir/trial/44150 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After baseline evaluations such as pulmonary function assessment tests by a pulmonary specialist, patients are included in the study according to inclusion and exclusion criteria. Then, they will be randomly divided into two treatment and control groups. Classification is done using a random number table. Classes by age (in the two age groups below A-50 and B-50 years and older) and literacy (A-read literacy has no web-literacy) It should be noted that the volume of each block is 4 cases, thus creating 6 different combinations of 4 blocks and randomly selecting the blocks, Blinding description: The capsules will be encoded by the individual as coders in two envelopes A and B. Patients will not be aware of the code allocation to the capsule envelope. Also, the researcher who provides the capsules to the clinic and the data analyst will not be aware of the contents of the envelope and the allocation of patients to the treatment and placebo groups. 3 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: In this group, 60 basil capsules will be taken by patients at a dose of 300 mg once daily at 22-22 hours, one to two hours before bedtime, and with a glass of water.The drug was developed at the Razi Plant Research Center under the supervision of Lorestan University of Medical Sciences. Intervention 2: Control group: In this group, placebo capsules (containing corn flour) will be administered by 60 patients at a dose of 300 mg once a night between 22-21pm, one to two hours before bedtime, and with a glass of water by patients.The placebo was built at the Razi Plant Research Center under the supervision of Lorestan University of Medical Sciences. 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 Its release schedule is still unclear
public Seyed Reza Hosseini Fard
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
Khorammabad Iran (Islamic Republic of) 381351698 +98 916 018 4818 reza.hfard@yahoo.com Khoram-Abad University of Medical Sciences scientific Mohammad Gholami
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
Khorammabad Iran (Islamic Republic of) 381351698 +98 912 509 1279 gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Male and female patients 40 to 80 years old and residing in Khorramabad city Sleep disorder with a high score of 5 (based on Pittsburgh Sleep Disorder Questionnaire) Cognitive dysfunction score below 26 (based on Montreal Cognitive Impairment Questionnaire) No history of allergy to ocimum extract Minimum literacy and ability to understand Persian language 40 years 80 years Both Illness, unstable hemodynamic status, life-threatening arrhythmias Affected by neurological diseases, cancer, acute infection and known mental disorders (anxiety, depression and delirium) The need for sleep medications (such as benzodiazepines, etc.) during the study Hospitalization during the study Participate in other Nairobi yoga and meditation cardiopulmonary rehabilitation programs Sensitivity to ocimum Extract for 2 consecutive days during study and non-use of ocimum Extract Capsule J44 Other chronic obstructive pulmonary disease Other Placebo Intervention group: In this group, 60 basil capsules will be taken by patients at a dose of 300 mg once daily at 22-22 hours, one to two hours before bedtime, and with a glass of water.The drug was developed at the Razi Plant Research Center under the supervision of Lorestan University of Medical Sciences. Control group: In this group, placebo capsules (containing corn flour) will be administered by 60 patients at a dose of 300 mg once a night between 22-21pm, one to two hours before bedtime, and with a glass of water by patients.The placebo was built at the Razi Plant Research Center under the supervision of Lorestan University of Medical Sciences. Cognitive performance score. Timepoint: Before the intervention, and one week after the 60-day treatment period. Method of measurement: Montreal Cognitive Impairment Questionnaire. Quality of sleep score. Timepoint: Before the intervention, and one week after the 60-day treatment period. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Khoram-Abad University of Medical Sciences Approved 2019-09-28 Ethics committee of Lorestan University of Medical Sciences Iran University of Medical Sciences, Lorestan, Khorram Abad, 5 Km. Khorram Abad Lorestan Iran (Islamic Republic of)