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IRCT20170315033086N8 IRCT 2021-01-06 Tehran University of Medical Sciences Efficacy of inflawell capsules on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia Efficacy of inflawell capsules containing Boswellic acids on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia 2019-09-23 anticipated 20 Complete https://irct.ir/trial/51717 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 2 Frontotemporal dementia. Intervention group: inflawell receiving group, 3 month, 3 times/day, oral administration (400 mg), inflawell containing Boswellic acids powders was manufactured in KondorPharma pharmaceutical Company (Canada), in orange gelatin capsules (400 mg / capsule) and were packed in brown containers.. Yes - There is a plan to make this available What will be shared: collected deidentified IPD, IPD collected for the primary outcome measure only When: Deidentified data will be available starting from April, 2024 To whom: People working in academic institutions or people working in businesse Conditions: No specific condition Where to obtain: Vajihe Aghamolaie, Roozbeh hospital, Tehran University of Medical Sciences, Tel: 00982155419151, How to obtain: The process is: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided in one month. Comments:
public Vajihe Aghamolie
After Lashgar crossroads, South Karegar Street
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 vajiheh102@gmail.com Tehran University of Medical Sciences scientific Vajihe Aghamolaie
After Lashgar crossroads, South Karegar St.
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 vajiheh102@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Behavioral variant of Frontotemporal dementia based on guideline: Rascovsky K, Hodges JR, Knopman D, et al. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011;134 Language variant of Frontotemporal dementia based on guideline: Gorno‐Tempini ML, Hillis AE, Weintraub S, et al. Classification of primary progressive aphasia and its variants. Neurology. 2011;76:1006‐1014 no limit no limit Both Other specific diseases of the central nervous system such as Parkinson's, multifactorial dementia, anterior brain dementia, Huntington's disease, hydrocephalus, brain tumors confirmed by MRI, severe paralysis of the nerve of the supernuclear body, epilepsy, clots between layers of brain tissue, multiple sclerosis and other dementias Taking NSAIDs and systemic corticosteroids for previous two months continuously Severe cardiovascular disease, kidney and liver disorders Psychiatric disorders include bipolar disorder and schizophrenia under medication Drugs or alcohol abuse Brain-related surgical interventions head trauma and progressive degenerative motor disorder Metabolic and systemic diseases G31.0 Frontotemporal dementia Treatment - Drugs Intervention group: inflawell receiving group, 3 month, 3 times/day, oral administration (400 mg), inflawell containing Boswellic acids powders was manufactured in KondorPharma pharmaceutical Company (Canada), in orange gelatin capsules (400 mg / capsule) and were packed in brown containers. Changes in the lesion area of brain. Timepoint: At the commencement of the investigation and 3 months after taking inflawell. Method of measurement: MRI ( Diffusion Tensor Imaging). Changes in cognitive and behavioral symptoms. Timepoint: At the commencement of the investigation and 3 months after taking inflawell. Method of measurement: Clinical cognitive tests: Behavioral inventory and FTD-Clinical dementia rating (FTD-CDR), Neuropsychiatry inventory (NPI), Frontal assessment buttery (FAB), Persian naming test (PNT). Tehran University of Medical Sciences Approved 2019-05-25 Ethics Committee of Tehran University of Medical Sciences, School of Medicine No 1, Poursina St., Ghods St., Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)