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Study aim:
Mean changes in systolic and diastolic blood pressure, pulse pressure, and treatment response by sex, and concomitant antihypertensive medication types and numbers.
Design:
Phase 2, randomized, double-blind, parallel-group, placebo-controlled clinical trial on 92 patients. Patient allocation to the intervention and control groups was performed using the minimization method to balance age, sex, and temperament
Settings and conduct:
This randomized, double-blind, placebo-controlled trial at Iran University of Medical Sciences involves patients with primary hypertension (stages I-II). For 6 weeks, patients receive standard care plus Asrol or placebo (twice daily). Allocation uses minimization, keeping patients, evaluators, and researchers blinded. Blood pressure is measured at baseline and weeks 2, 4, and 6; lab tests are evaluated at baseline and study end.
Participants/Inclusion and exclusion criteria:
Inclusion Criteria:
Patients aged 18 to 80 years with stage one or two primary hypertension
Exclusion Criteria:
Very high blood pressure; cardiovascular or cerebrovascular diseases; allergy; use of neurological medications, anticoagulants, antiplatelet drugs; hypothyroidism medications; liver or kidney disease; pregnancy; breastfeeding; history of peptic ulcer; gynecomastia; sexual dysfunction; nasal issues
Intervention groups:
Control group: Standard treatment+ placebo
Intervention group: Standard treatment + Asrol
Main outcome variables:
Mean systolic and diastolic blood pressure