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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
IRCTID: IRCT20130207012391N3
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