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IRCT20191212045709N3 IRCT 2020-11-14 Shiraz University of Medical Sciences Assessment of the impact of a memory enhancer traditional oral formulation in management of dementia, a randomized controlled clinical trial. Assessment of the impact of a memory enhancer traditional oral formulation in management of dementia, a randomized controlled clinical trial. 2019-07-23 anticipated 66 Complete https://irct.ir/trial/51935 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 66 patients were randomly divided in to two groups of 33 each in a randomized double-blind placebo-controlled design using permuted block randomization method. Samples are randomized by random blocking method with 4 blocks and by using the table of random numbers of the Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. Minimum sample size for each group was 13 patients. All patients received 2 capsules of the same-looking drug or placebo twice daily for 6 months, Blinding description: The study will be a double blind trial and only the evaluator knows the results and the code of the drug or placebo group.The capsules of the drug group and the placebo are quite similar in appearance.The drug and placebo groups will be separated by receiving a code. 3 alzheimer disease. Intervention 1: Intervention group: take 4 capsules daily, including pepper (one part), black cumin (one part) and sugar (3 parts) along with underlying drugs to control Alzheimer's for 6 months. The total consumption of the product per day is equal to 4.2 grams. Intervention 2: Control group: take 4 capsules containing starch daily as a placebo along with underlying drugs to control Alzheimer's for 6 months. Brain imaging and measurement of B12 and TSH levels are performed at the beginning and end of the study. 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 not yet known
public Mohammad Mehdi Zarshenas
zand street
shiraz Iran (Islamic Republic of) 7139745197 +98 910 700 1164 ZARM@SUMS.AC.IR Shiraz University of Medical Sciences scientific Mohammad Mehdi Zarshenas
zand street
shiraz Iran (Islamic Republic of) 7139745197 +98 917 711 3491 ZARM@SUMS.AC.IR Shiraz University of Medical Sciences Iran (Islamic Republic of) diagnosis of dementia based on DSM criteria no limit no limit Both patients with cardiovascular disease pregnancy breast feeding sensitivity to herbal medicines present in formulation patients with depression patients with peptic ulcer disease G32 Other degenerative disorders of nervous system in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: take 4 capsules daily, including pepper (one part), black cumin (one part) and sugar (3 parts) along with underlying drugs to control Alzheimer's for 6 months. The total consumption of the product per day is equal to 4.2 grams. Control group: take 4 capsules containing starch daily as a placebo along with underlying drugs to control Alzheimer's for 6 months. Brain imaging and measurement of B12 and TSH levels are performed at the beginning and end of the study. TSH serum level. Timepoint: every 6 months. Method of measurement: serum sample. B12 serum level. Timepoint: every 6 months. Method of measurement: serum sample. Shiraz University of Medical Sciences Approved 2019-10-26 Ethics committee of Shiraz University of Medical Sciences shiraz- zand street shiraz Fars Iran (Islamic Republic of)