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IRCT20210701051755N1 IRCT 2021-09-16 Tehran University of Medical Sciences Evaluation of the effectiveness of Boswellia -based herbal powder mixture in improving of Alzheimer's patients Evaluation of the effectiveness of herbal mixture based on Boswellia in improving cognitive and behavioral disorders in patients with mild to moderate Alzheimer's disease ,A Randomized Double-Blind Clinical Trial with Placebo-Controlled. 2021-09-21 anticipated 64 Complete https://irct.ir/trial/57262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by random block method, randomization with 4 blocks, and using Random Allocation Software will be specified from the random number table. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The allocation ratio of the samples was Allocation 1: 1 and they will be placed in two groups receiving herbal capsules and placebo. The sequence of allocation, drugs will be given to patients, Blinding description: This study is designed to be double-blind. labeling Research will be done on two products. All case medications Consumption in the closed study was completely opaque and in them with The disposable label will be packaged. On this code pack Corresponding to randomization is inserted. Thus the effect and the doctor Investigator of clinical implications of increased allocation in treatment groups.It was accepted that at the end all the data is encrypted The direction of analysis will be increased. 3 Mild to moderate Alzheimer's. Intervention 1: Intervention group: 3 packs of 30 oral herbal capsules of 500 mg (Boswellia as the main component about 160 mg, physalis or puppet behind the curtain, cinnamon and peppermint 14 mg each and about 240 mg of sugar) three times a day, With every meal, for 3 months, By partner laboratories of the Ministry of Health and Medicinal Plants Research Institute. Intervention 2: Control group: 3 packs of 30 oral placebo capsules, three times a day, With every meal, for 3 months, By partner laboratories of the Ministry of Health and Medicinal Plants Research Institute. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of confidentiality
public Mahsa Panahishokouh
Saadat Abad, Sarv Intersection, Payam Blvd., Shahid Ahangrani St., Pasargad Town, Block 40, Third Floor
Tehran Iran (Islamic Republic of) 1981819646 +98 21 2213 2705 mahsapanahishokooh@ gmail.com Tehran University of Medical Sciences scientific Niayesh Mohebbi
South Kargar Street, below the Lashgar intersection
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9 m.yahoo@mohebbi_niayesh Tehran University of Medical Sciences Iran (Islamic Republic of) people over 50 years old who have been diagnosed with mild to moderate Alzheimer's disease based on a clinical interview with a DSM-V neurologist Minimum primary education 50 years no limit Both Major psychiatric disorders such as depression, schizophrenia; psychotic disorders Other causes of dementia include pure vascular dementia, airway dementia, and frontotemporal dementia. Treatable causes of dementia such as metabolic disorders Patients with severe hepatic impairment (Child-Pugh class c), renal (GFR <25 ml / min) and cardiac (EF <15%) Taking the drug memantine Taking any medication or herbal supplement with an effect on cognitive function Reluctance to continue the plan, at any time and for any reason during the study Serious side effects during treatment G30 Alzheimer's disease Treatment - Drugs Placebo Intervention group: 3 packs of 30 oral herbal capsules of 500 mg (Boswellia as the main component about 160 mg, physalis or puppet behind the curtain, cinnamon and peppermint 14 mg each and about 240 mg of sugar) three times a day, With every meal, for 3 months, By partner laboratories of the Ministry of Health and Medicinal Plants Research Institute Control group: 3 packs of 30 oral placebo capsules, three times a day, With every meal, for 3 months, By partner laboratories of the Ministry of Health and Medicinal Plants Research Institute Score of cognitive disorders in MMSE, MOCA questionnaires. Timepoint: 3 months from the start of the study. Method of measurement: MMSE(Mini–mental state examination), MOCA(montreal cognitive assessment). Behavioral Disorders Score in NPI Questionnaire. Timepoint: 3 months from the start of the study. Method of measurement: (Neuropsychiatric Inventor)NPI test. Investigation of side effects. Timepoint: monthly. Method of measurement: Ask questions of the patient and record information. Tehran University of Medical Sciences Approved 2021-09-12 Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences Poursina St., Tehran University of Medical Sciences, Faculty Pharmacy, Institute of Pharmaceutical Sciences (TIPS), (PO Box). 14176-13151, Iran Tehran Tehran Iran (Islamic Republic of)