]>
IRCT20160702028742N8 IRCT 2020-03-20 Shahid Beheshti University of Medical Sciences Effect of powdered Berberis vulgaris on vascular function Comparison of the effect of powdered Berberis vulgaris and placebo consumption on flow mediated dilation and vascular inflammatory biomarkers in hypertensive subjects 2020-01-21 anticipated 76 Complete https://irct.ir/trial/44548 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, 76 subjects with previous history of hypertension and on hypertension medication will be randomized into two groups: barberry or placebo for 2 months. Stratified block randomization will be employed to assign subject to each of the two groups. Stratification subdivides patients into those with diabetes or without diabetes and in each stratum, blocks of size 4 (two intervention and two placebo) will be defined and then the patients within each block will be assigned to intervention and control groups, Blinding description: Patients are blinded of the type of powder they are consuming, but the main investigator who assigns patients to intervention or placebo groups is not blinded. Powders are given to patients in undetectable non-transparent packaging. N/A hypertension. Intervention 1: Intervention group: Daily consumption of 10 gram of barberry powder for 8 weeks. Barberry is purchased from the local market at one time. Intervention 2: Control group: Daily consumption of 10 gram of placebo powder (Contains maltodextrin, citric acid and edible red color) for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Hadi Emamat
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
Tehran Iran (Islamic Republic of) 1981619573 +98 31 5545 0314 hadiemamat@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr Javad Nasrollahzadeh
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7424 jnasrollahzadeh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age between 20-65 years Having elevated blood pressure (129/ < 85) or known hypertensive patients on medical treatment At least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus 20 years 65 years Both BMI> 30 Patients on nitrate drugs High doses of statins consumption (Atorvastatin>40 mg/day or Rosuvastatin>20 mg/day) Regular consumption (more than once in a week) of vitamins or minerals supplements during past month Chronic kidney disease stage 4 or 5 I10 Essential (primary) hypertension Treatment - Other Placebo Intervention group: Daily consumption of 10 gram of barberry powder for 8 weeks. Barberry is purchased from the local market at one time. Control group: Daily consumption of 10 gram of placebo powder (Contains maltodextrin, citric acid and edible red color) for 8 weeks Flow mediated dilation (FMD). Timepoint: Baseline and the end of the study. Method of measurement: sonography. Plasma ICAM-1. Timepoint: Baseline and the end of the study. Method of measurement: ELISA. Plasma VCAM-1. Timepoint: Baseline and the end of the study. Method of measurement: ELISA. Shahid Beheshti University of Medical Sciences Approved 2019-09-02 Ethics Committee of Shahid Beheshti University of Medical Sciences No. 46, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)