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IRCT20190428043409N1 IRCT 2019-09-21 Tabriz University of Medical Sciences effect of saffron on dementia Effect of Crocus sativus stigma ethanolic extract on cognitive criteria, anti-inflammatory and antioxidant markers in Nesyan patients (Alzheimer's disease) 2019-10-23 anticipated 60 Complete https://irct.ir/trial/39206 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be coded and randomly assigned random numbers in the placebo or saffron group, Blinding description: Capsules can be placed in plastic cans in the form of placebo boxes and coded to blinding both (clinical caregiver) and drug receptor (participant). To evaluator blinding, the questionnaires will be without a name and with reference codes. To control blindness, the saffron and control group (drug or placebo) will not be mentioned. 3 Dementia - alzheimer. Intervention 1: Intervention group: Giving the extract (capsule) of saffron 15mg of the company's "green herbal products", twice a day. Intervention 2: Control group: Starch containing capsules twice a day. Yes - There is a plan to make this available What will be shared: The data on the main outcome is shared When: Information will be available 6 months after the publication of the paper To whom: Researchers working in academic and scientific institutions Conditions: Information will be available for further research and similar studies. The publication of articles using the results of this research will only be allowed by researchers. If more papers are published using the data in this study, the intellectual property rights of the researchers should be considered. Where to obtain: leila rasi marzabadi email.address: leili_rasi_m@yahoo.com How to obtain: If the request does not include unusual items, the information will be provided to them at least 10 working days after the approval of the Research Director of the Neuroscience Research Center. Comments:
public Leila Rasi marzabadi
Traditional medicine faculty,university avenue,tabriz university
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 9528 leili_rasi_m@yahoo.com Tabriz University of Medical Sciences scientific Leila Rasi marzabadi
Traditional medicine faculty,university avenue,tabriz university
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 9528 leili_rasi_m@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 1) Man and woman Patients older than 65 years (Late Onser Alzheimer Disease) Diagnosis of dementia based on DSM5 criteria and diagnosis of neurologist (confirmation with brain MRI and blood tests to exclude other causes) 3. Mild to moderate Alzheimer disease based on the MMSE cognitive test score between 11 and 24 65 years no limit Both Reversible dementias include delirium, pharmacotic agents, endocrine causes (hypothyroidism), metabolic causes, electrolyte, SOL, infections (encephalitis, syphilis, and AIDS) and atherosclerosis. irreversible cortical causes including fronto-temporal and lewy body dementia. irreversible subcortical causes include degenerative causes (such as corticobasal ganglia), inflammatory causes (such as lupus, vasculitis and multiple sclerosis) The cases that change the anti-inflammatory criteria of a person, such as fever, acute infectious diseases, vasculitis, antioxidant medications, anti-inflammatory drugs such as corticosteroids (such as asthma, rheumatoid arthritis, etc.) Patients with any other psychological or neurological disease based on DSM5 criteria. People with MMSE score higher than 24 (MCI) and below 11 (severe dementia) do not enter the study. G30.1 Alzheimer's disease with late onset Treatment - Drugs Placebo Intervention group: Giving the extract (capsule) of saffron 15mg of the company's "green herbal products", twice a day Control group: Starch containing capsules twice a day Memory scores in the mini mental state exam(MMSE) questionnaire. Timepoint: MMSE measurements at the beginning of the study (before the intervention) and 16 weeks after the intervention. Method of measurement: mini mental state exam. Tumor necrosis factor alpha. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: laboratory kits. Interleukin 6. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: Laboratory kits. Interleukin 1 beta. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: Laboratory kits. Glutathione peroxidase. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: Laboratory kits. Superoxid dismutase. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: Laboratory kit. Total Antioxidan Capacity. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: Laboratory kit. Serum levels of malondialdehyde. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: laboratory kits. Memory level. Timepoint: The beginning of the study (before the intervention) and 16 weeks after the start of the intervention. Method of measurement: MMSE questionnaire. Tabriz University of Medical Sciences Approved 2019-07-15 National Ethics Committee for Biomedical Research 82No, Ghaem alley,Karpishe street, Dr.gharib Street,Azadi Street Tabriz East Azarbaijan Iran (Islamic Republic of)