Evaluating Asrol Capsule as an Add-on to Standard Treatment for Primary Hypertension: A Randomized, Double-blind, Placebo-controlled Trial

Mean changes in systolic and diastolic blood pressure, pulse pressure, and treatment response by sex, and concomitant antihypertensive medication types and numbers.

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

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.

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

Control group: Standard treatment+ placebo Intervention group: Standard treatment + Asrol

Mean systolic and diastolic blood pressure

Simple random sampling will be used to recruit eligible participants with primary hypertension. After screening based on the predefined inclusion and exclusion criteria, a unique identification number will be assigned to each eligible individual, and the required number of participants will be selected using a random numbers table. Conventional randomization methods are not effective in randomized clinical trials of Persian medicine because they do not take individuals’ temperament characteristics into account. During the randomization process, the treatment groups may differ significantly in some prognostic and temperament-related factors, particularly when the sample size is relatively small (less than 200). If these factors have important effects on the study’s primary or secondary outcomes, any significant differences in the levels of these factors will affect the trial results. Various methods are used to overcome the problem of unmatched experimental groups, including minimization and stratification, with minimization providing more acceptable

This study will be conducted as a double-blind trial. To maintain blinding, the Asrol capsules and their placebo will be identical in terms of shape, size, color, packaging, and labeling. In addition, the placebo for the standard antihypertensive medication will be similar to the active product in appearance and administration schedule. Accordingly, all participants in both groups will receive the standard medication and the study capsules in similar packaging, and participants, investigators, and outcome assessors will remain unaware of group allocation. The allocation code will be kept by the statistician until the end of the study, and the participants, investigators, and outcome assessors will remain unaware of group allocation.

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