Effect and safety of Yiqi-Shengjin granules in hypertension management among patients with abnormal glucose metabolism: a study protocol for a randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND

The co-occurrence of hypertension and abnormal glucose metabolism-a spectrum encompassing prediabetes and diabetes-substantially elevates the risk of cardiovascular disease (CVD). Effective management of this high-risk clinical overlap remains a therapeutic challenge. Yiqi-Shengjin granules (YQSJ), a traditional Chinese herbal formulation, have been employed as a hospital preparation at Beijing Hospital of Traditional Chinese Medicine for over three decades, primarily for the management of glucose metabolism disorders, with an annual treatment cohort exceeding 1,000 patients. Although preliminary clinical observations suggest potential benefits of YQSJ in patients with hypertension complicated by diabetes, robust evidence from standardized clinical trials is lacking. Therefore, a well-controlled clinical study is warranted to systematically evaluate the efficacy and safety of YQSJ in this specific population.

METHODS/

DESIGN

This will be a randomized, double-blind, placebo-controlled study. After being screened and providing signed informed consent, participants will be evenly assigned to experimental or control groups in a 1:1 ratio. The experimental group will receive YQSJ 3 g twice daily and losartan 50 mg once daily, whereas the control group will receive YQSJ placebo 3 g twice daily and losartan 50 mg once daily. The treatment period will last for a total of 8 weeks (56 days), with follow-up visits scheduled every 2 weeks. The primary endpoint will be the difference in drug efficiency between the two groups. The secondary endpoints include 24 h blood pressure indicators, glucose metabolism indicators, lipid metabolism indicators, vascular damage indicators, insulin resistance indicators, oxidative stress indicators, and major adverse cardiovascular events (MACE). Safety and efficacy outcomes will be assessed both before and after the 8-week medication period.

DISCUSSION: This study aims to provide clinical evidence on the efficacy and safety of YQSJ in the treatment of hypertension in patients with abnormal glucose metabolism. Furthermore, we will explore the potential mechanism through which YQSJ might exert hypotensive effects and adjust glucose metabolism by examining pertinent indicators of vascular and oxidative stress, as well as its influence on clinical symptoms, risk factors associated with hypertension, and the target organs affected by this condition.

CLINICAL TRIAL REGISTRATION: identifier ChiCTR2200062453.