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IRCT20090117001556N148 IRCT 2023-03-14 Tehran University of Medical Sciences The effect of saffron in patients with mild cognitive impairment The effect of saffron (Crocus sativus) capsules for patients with mild cognitive impairment: a double-blind, placebo-controlled study 2023-04-21 anticipated 50 Complete https://irct.ir/trial/69133 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Mild cognitive impairment. Intervention 1: Control group: patients take placebo capsules twice a day. Intervention 2: Intervention group: patients take saffron capsules with a dose of 15 mg twice a day. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2023 to 2028 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof. Shahin Akhondzadeh How to obtain: By E-mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Rey-AVLT<=8 Radiological Criteria: Bilateral Hippocampal volume <= ۳.۶۳cc Radiological Criteria: Entorhinal cortex thinking <=۳.۲۵ m 40 years 70 years Both The presence of an uncontrolled acute or chronic physical illness or a marked disturbance in the patient's tests The presence of any neurological disease that leads to cognitive disorders, such as epilepsy or developmental and neurometabolic disorders and brain system inflammations History of moderate and severe head trauma Uncontrolled acute or chronic psychiatric illness including psychosis or mood disorder and severe depression Any history of drug or alcohol abuse Severe visual or motor impairment that prevents the implementation of the virtual reality navigation test The presence of any contraindications to MRI during the study G31.84 Mild cognitive impairment, so stated Placebo Treatment - Drugs Control group: patients take placebo capsules twice a day Intervention group: patients take saffron capsules with a dose of 15 mg twice a day. Severity of mild cognitive impairment. Timepoint: Weeks 0, 6, 12. Method of measurement: By Rey AVLT ، (MoCA (Montreal Cognitive Assessment. Tehran University of Medical Sciences Approved 2022-12-18 Ethics Committee of School of Medicine, Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)