[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial of Bushenhemai granules in the treatment of isolated systolic hypertension (kidney qi deficiency type) in the elderly
主要目的:评价补肾和脉颗粒治疗老年单纯收缩期高血压的有效性和安全性。
次要目的:对补肾和脉颗粒治疗老年单纯收缩期高血压的给药剂量、疗程进行探索,以确定后续III期研究的给药剂量。
探索性目的:初步探索老年单纯收缩期高血压患者服用补肾和脉颗粒后血清中的一氧化氮(NO)浓度、内皮素(ET)浓度、一氧化氮/内皮素比值(NO/ET)、尿微量白蛋白浓度的变化。
[Translation] Primary objective: To evaluate the efficacy and safety of Bushen Hemai granules in the treatment of isolated systolic hypertension in the elderly.
Secondary objective: To explore the dosage and course of Bushen Hemai granules in the treatment of isolated systolic hypertension in the elderly, so as to determine the dosage for subsequent phase III studies.
Exploratory objective: To preliminarily explore the changes in serum nitric oxide (NO) concentration, endothelin (ET) concentration, nitric oxide/endothelin ratio (NO/ET), and urinary microalbumin concentration in elderly patients with isolated systolic hypertension after taking Bushen Hemai granules.