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IRCT20231031059912N1 IRCT 2024-01-22 Vice Chancellor for Research & Technology Studying the effect of almond on Alzheimer's disease Evaluation of the effectiveness of "Prunus dulcis" on Alzheimer's diseases 2020-12-21 anticipated 60 Complete https://irct.ir/trial/73914 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the block randomization method and in this two-group clinical trial, we will have 4 blocks. For each person who enters the study, a code is obtained from the software and it is determined which group (intervention or control) it belongs to. The working tool is Random Allocation Software. This software can be downloaded for free from the following address: https://random-allocation-software.software.informer.com/2.0 In the mentioned software, the number of two groups and the sample size is 100, the block method with random sizes is selected and the output is the randomization list. In order to conceal, we use specialized random Allocation concealment, this method is such that the allocated group is not known before the individual is allocated, in this way, by using opaque envelopes marked with a random sequence, which in In this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. Finally, the lids of the envelopes are glued and placed in a box. Blocking and preparation of envelopes is done by a person not involved in data sampling and analysis. In this way, the person who collects, the person who analyzes, and the person who participates do not know the type of intervention received and in which group each person is placed. 0 (exploratory trials) Alzheimer. Intervention 1: "Intervention group": Sweet almond obtained from central Zagros regions in the amount of 10 grams per day, slightly sweetened with cantaloupe powder (about one tablespoon) were consumed by the intervention group for three months. Intervention 2: "Control group": The control group does not use drugs and the questionnaire is completed only before and after the study. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 3 months after the results are published To whom: Researchers working in academic and scientific institutions and other people Conditions: There is no limit for scientific use and exploitation of the results. However, the questionnaires of people's diseases must remain completely confidential. Where to obtain: For use, they can refer to the library website of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Also, use the articles extracted from the research work and published in magazines. How to obtain: A person should visit the library and use the results after membership or through guest membership. Also, by referring to websites related to magazines, he can access articles. Comments:
public Dr. Mohsen Mohajeri
First Floor, No. 847,Iranian Medicine collogue of Iran Medical Science University, Vahdat Eslami ave. cross of Behesht Street. Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 Mo_mohajeri@yahoo.com Iran University of Medical Sciences scientific Dr. Mohsen Mohajeri
First Floor, No. 847,Iranian Medicine collogue of Iran Medical Science University, Vahdat Eslami ave. cross of Behesht Street. Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 Mo_mohajeri@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed based on history and questionnaire and examination and paraclinic under the supervision of psychiatrist or neurologist or geriatrics specialist Having no other psychiatric disease causing dementia other than Alzheimer's based on the opinion of a specialist Not having severe non-psychiatric and non-neurological diseases based on the opinion of a specialist Not abusing substances or drugs (except nicotine and caffeine) such as narcotics or stimulants Informed written consent of the patient or the patient's guardian to enter the plan 60 years 95 years Both Uncontrolled diabetes mellitus because the almonds are slightly sweetened with candy F00.1 Dementia in Alzheimer disease Treatment - Other Treatment - Other "Intervention group": Sweet almond obtained from central Zagros regions in the amount of 10 grams per day, slightly sweetened with cantaloupe powder (about one tablespoon) were consumed by the intervention group for three months. "Control group": The control group does not use drugs and the questionnaire is completed only before and after the study. Change in score of MMSE and FAST questionnaires, CDR and MoCA and sleep questionnaire. Timepoint: Completing the questionnaire at the beginning of the study (before the start of the intervention) and 3 months after starting to consume almonds. Method of measurement: MMSE، MoCA، CDR، FAST and sleep questionnaires. Complications. Timepoint: The time periods of completing the questionnaire as a secondary outcome, at the beginning of the study (before the start of the intervention) and 3 months after consuming almonds. Method of measurement: MMSE and FAST, CDR and MoCA and sleep questionnaires. Vice Chancellor for Research & Technology Approved 2020-12-13 Iran University of Medical Sciences (Research Ethics Committee) Unit 220, Second Floor, The central building of the university,Vice Chancellor for Research & Technology, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)