]>
IRCT20170315033086N4 IRCT 2019-04-12 Shahid Beheshti University of Medical Sciences The effect of Boswellia resin extract on treatment of patients with Parkinson's disease Boswellia resin extract effect on plasma levels of inflammatory cytokines in patients with Parkinson's disease 2017-06-22 anticipated 50 Complete https://irct.ir/trial/25618 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is designed based on four-sized block randomization. An unordered computer list is generated by an epidemiologist. Codes are written on envelopes and medication bottles. Patients allocation and sequencing are done blind, Blinding description: Patients allocation is done in a blinded manner. All staffs who are involved to perform the enrollment, physicians, nurses and investigator team are all masked. 3 Parkinson 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: Bahram Yaghmayi, Shahid Madani St., Tehran, Iran, Tel: +982123872570 Mob. 09215450282 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 Shahid Beheshti University of Medical Sciences
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2570 msp@sbmu.ac.ir Bahram Yaghmayi scientific Bahram Yaghmayi
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2570 msp@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) In accordance to UPDRS, only pationts in mild and moderate stage will be recruited No background of parkinson desease in patient’s family. It must be recorded in the primary questionnaire. The substance consumed in this research make no conflict with prescribed medicines by the physician, and all the patients recruited in this study will receive the same combination of medicines. BMI between 18 to 25, this parameter is determined by researcher and physician. No background of peptic ulcer, any surgery of digesting system, or haemorrhage of digesting system Age between 55 and 85 No severe heart or vascular disease No kidney or liver disorder 55 years 85 years Both Acute or severe infectious disease (viral, bacterial) during research G20 Parkinson 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. Method of measurement: ELISA assay kit. Shahid Beheshti University of Medical Sciences Approved 2016-06-05 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)