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IRCT20170315033086N3 IRCT 2019-04-08 Shahid Beheshti University of Medical Sciences The Investigation on the Effect of Boswellia resin Extract on Plasma Levels of inflammatory factors in Patients with Alzheimer’s disease The Investigation on the Effect of Boswellia resin Extract on Plasma Levels of inflammatory factors in Patients with Alzheimer’s disease 2017-05-23 anticipated 50 Complete https://irct.ir/trial/38378 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was designed based on four-sized block randomization. A non-ordering computer sequence list was generated by an epidemiologist. Codes were written on envelopes and medication bottles. Patients allocation and sequencing were done blind. Following patients assessment by doctor, according to the admission sequence, the envelopes with the same number will be opened. Then according to the bottle code which is written in envelope, bottle will be given to patients, Blinding description: Patients allocation and sequencing are done blind. All staffs who were involved to perform the enrollment, physicians, nurses and investigator team are all masked. Therefore, nobody knows the intervention is Boswellic resin extract or placebo. N/A Alzheimer's disease. Intervention 1: Intervention group: Boswellia Resin extract receiving group, 3 times/day (400 mg). Intervention 2: Control group: Placebo group, 3 times/day (400 mg). 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, 2021 To whom: People working in academic institutions or people working in businesses. Conditions: No specific condition Where to obtain: Behnam Safarpour Lima, Shahid Madani St., Tehran, Iran, Tel: +982173433000 Mob. 091229811576 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 two weeks. Comments:
public Behnam Safarpour Lima
Shahid Madani St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1617948615 +98 16 1794 8615 info@ehmc.ir Shahid Beheshti University of Medical Sciences scientific Behnam Safarpour Lima
Shahid Madani St., Tehran,
Tehran Iran (Islamic Republic of) 1617948615 +98 21 7343 3000 info@ehmc.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Positive DSM-IV Positive NINCDS/ ADRDA MMSE includes 10-26 No family history of Alzheimer's disease Hamilton test is less than or equal to 12 in 17th item Memory score below 1 BMI includes 18-25 No background of peptic ulcer,surgery of digesting system, or haemorrhage of digesting system No taking NSAIDs or systemic corticosteroid during previous two months No alcohol consumption Age range is 55-85 55 years 85 years Both Turning to negative DSM-IV during Boswellia resin extract period Turning to positive NINCDS/ ADRDA during Boswellia resin extract period Acute viral, bacterial or severe infectious disease during research G30 Alzheimer's disease Treatment - Drugs Placebo Intervention group: Boswellia Resin extract receiving group, 3 times/day (400 mg) Control group: Placebo group, 3 times/day (400 mg) Pro- and anti-inflammatory factors. Timepoint: At the recruitment day and after intervention period. Method of measurement: ELISA assay kit. MMSE (Mini-Mental State Examination) test. Timepoint: At the recruitment day and after intervention period. Method of measurement: MMSE questionnaire (contained 30 question point involved evaluation of attention and calculation, recall, ability to follow simple commands and orientation). Shahid Beheshti University of Medical Sciences Approved 2016-11-15 Ethics committee of Shahid beheshti University of Medical Sciences, School of Medicine Ground floor, medical faculty, Koodakyar Alley, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)