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IRCT20150919024080N16 IRCT 2020-08-25 Khoram-Abad University of Medical Sciences The effect of rosemary on cognitive and pulmonary function and daily activity The effect of hydroalcoholic rosemary extract on cognitive function، pulmonary function and physical activity daily of living of patients with chronic obstructive pulmonary disease 2020-08-22 anticipated 80 Complete https://irct.ir/trial/49366 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. Randomisation is done using a random number table، stratification by age (in the two age groups below A-50 and B-50 years and older )and disease classes 1،2 and 3 are based on GOLD criteria and patients will be divided into two groups based on 4 or 6 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 contents of the envelope and the allocation of patients to the treatment and placebo groups. 3 COPD. Intervention 1: Intervention group: In this group،60 capsules of rosemary extract with a dose of 500 mg twice at 7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and they will be consumed by patients with a glass of water.this drug is prepared by Goldaro Pharmaceutical Company located in Isfahan and is weighed and packaged in a sterile environment inside 500 mg capsules by the expert of Khorman Daru Khorramabad Company. Intervention 2: Control group: In this group،60 capsules of Placebo (containing corn flour) with a dose of 500 mg twice at 7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and they will be consumed by patients with a glass of water.the placebo is prepared and weighed by Khoraman Daroo Company. 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 No more information
public Arash momeni safarabadi
Khorramabad-Razi Square-Alley Arasteh One
Khorramabad Iran (Islamic Republic of) 6816864716 +98 66 3255 5012 arashmomeni1373@gmail.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) 6814993165 +98 912 509 1279 gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Age between 40 and 80 years The ratio of FEV1 to FVC is less than 0.7 exhalation pressure volume per second (FEV1)،less than 70% of reference value and increase in FEV1 less than 10% after inhalation of beta-two agonists Detection of COPD based on grade one to three gold criteria approved by spirometry and physician Patients with mild to moderate cognitive impairment based on MMSE test with a minimum score of 23 Have a history of smoking at least ten packs of cigarettes a year At least one year has passed since the diagnosis of COPD in the patient Do not take any herbal medicine supplements effective in improving cognitive function and lung function and daily activity (such as Ginseng،Thyme،Nigella sativa،Chamomile،etc)from two months ago No alcohol،hookah and drugs Do not take antioxidants as a supplement during the last three months(vitamin E،Omega3،α-tocopherol،etc) 40 years 80 years Both Lack of motivation of the patient to continue cooperation Hospitalization during the study Neurological disease،cancer،acute infection and known mental disorders(anxiety،depression and delirium) Patient deterioration،unstable hemodynamic status،life threatening arrhythmias Participate in other pulmonary rehabilitation programs or meditation and yoga Do not take the capsules for two consecutive days Demonstrate sensitivity to capsules If the patient needs to take drugs that affect cognitive or pulmonary function or the amount of daily activity (such as muscle relaxants،etc)during the study،in addition to the main treatment drugs،excluded from the study Patients receiving vasodilators include organic nitrates and people with pulmonary ،hypertension،obstructive sleep apnea،malignancies،gastrointestinal abnormalities،recent surgery،severe endocrine disease،kidney disease،liver disease،inflammatory and infectious disease،and musculoskeletal disease active that causes impairment in exercise and respiratory capacity J44 other chronic obstructive pulmonary disease Other Placebo Intervention group: In this group،60 capsules of rosemary extract with a dose of 500 mg twice at 7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and they will be consumed by patients with a glass of water.this drug is prepared by Goldaro Pharmaceutical Company located in Isfahan and is weighed and packaged in a sterile environment inside 500 mg capsules by the expert of Khorman Daru Khorramabad Company. Control group: In this group،60 capsules of Placebo (containing corn flour) with a dose of 500 mg twice at 7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and they will be consumed by patients with a glass of water.the placebo is prepared and weighed by Khoraman Daroo Company. Cognitive function. Timepoint: Before starting treatment and one week after completing the 60 day treatment period. Method of measurement: Montreal Cognitive Dysfunction Questionnaire. Pulmonary function. Timepoint: Before starting treatment and one week after completing the 60 day treatment period. Method of measurement: Spirometry device. Activity daily of living. Timepoint: Before starting treatment and one week after completing the 60 day treatment period. Method of measurement: Lawton and London Questionnaire. Khorramabad University of Medical Sciences Approved 2020-05-09 Ethics Committee of Lorestan University of Medical Sciences km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran Khorammabad Lorestan Iran (Islamic Republic of)