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Effects of sang-qi granules on blood pressure and endothelial dysfunction in stage I or II hypertension: study
Haoyue Shi1, Deshuang Yang2, Jiajun Qiao2
1Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Dong Cheng District, Beijing, 100010, China.
Insights
This study investigates the efficacy of sang-qi granules (SQG) for hypertension. Results will determine if SQG improves endothelial function and offers a new treatment for high blood pressure.
Area of Science:
- Cardiovascular Medicine
- Integrative and Complementary Medicine
- Pharmacology
Background:
- Hypertension is a global health challenge, contributing significantly to cardiovascular and cerebrovascular diseases.
- Vascular endothelial dysfunction is a key factor in the development of essential hypertension.
- Sang-qi granules (SQG), a traditional Chinese herbal formula, show potential in preclinical studies for managing hypertension.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of sang-qi granules (SQG) in treating patients with stage I or II hypertension.
- To explore the potential mechanisms of SQG in lowering blood pressure, focusing on its effects on vascular endothelial function.
- To assess the impact of SQG on clinical symptoms, risk factors, and target organ damage associated with hypertension.
Main Methods:
- A randomized, double-blind, double-simulation controlled trial involving 300 patients with stage I or II hypertension.
- Participants were allocated to three groups: SQG with Losartan placebo, Losartan with SQG placebo, or combined SQG and Losartan.
- Primary endpoint: drug efficiency; Secondary endpoints: changes in blood pressure, target organ damage markers, symptom assessments, blood lipids, and vascular function indicators.
Main Results:
- The study is designed to provide primary data on drug efficiency across the three treatment arms.
- Secondary outcome measures will assess changes in systolic and diastolic blood pressure, nocturnal blood pressure dipping, and markers of target organ damage.
- Evaluation of SQG's impact on vascular endothelial function, including serum levels of key vasoactive substances, will be conducted.
Conclusions:
- This trial aims to establish clinical evidence for the effectiveness and safety of SQG in hypertension management.
- The study will elucidate the role of SQG in improving endothelial function and its broader effects on hypertension-related complications.
- Findings may support SQG as a valuable therapeutic option for hypertension, potentially through mechanisms involving vascular health.
Background:
Worldwide, hypertension is an important public health challenge because of its high prevalence and the concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximately two-thirds of the cerebrovascular disease burden. Vascular endothelial dysfunction has important roles in the pathophysiology of essential hypertension. Types I and II hypertension can be treated with sang-qi granules (SQG), a Chinese herbal formula. Several experimental studies on animals have shown that SQG can lower blood pressure and myocardial fibrosis by suppressing inflammatory responses. However, no standard clinical trial has confirmed this. Whether SQG can improve endothelial cell function is unknown.
Methods/Design:
In this randomized double-blind double-simulation controlled trial, 300 patients with stage I or II hypertension will be recruited and randomly allocated in a 1:1:1 ratio to group A (treatment with SQG and placebo instead of Losartan), group B (treatment with Losartan and placebo instead of SQG), and group C (treatment with SQG and Losartan). In this study, 10 g of SQG (or its placebo) will be administrated twice a day and 50 mg of Losartan (or its placebo) will be administrated once in the morning. The primary endpoint is the drug efficiency for each of the three groups. The secondary endpoints are the change in average systolic and diastolic blood pressure during the day and the night, the change in the rate at which blood pressure drops at night, assessment of target organ damage (heart rate variability, ankle-brachial pressure index, and pulse wave velocity), assessment of any improvement in symptoms (Hypertension Symptom Scale, syndrome integral scale in traditional Chinese medicine, Pittsburgh Sleep Quality Index Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and the 36-Item Short Form Health Survey), blood lipids, serum indicators of vascular function (changes in serum levels of ET-1, TXA2, NO, and PGI2), and safety indicators.
Discussion:
This study aims to provide clinical evidence on the efficacy and safety of SQG in the treatment of hypertension. Moreover, the possible mechanism by which SQG may lower blood pressure will be explored by observing the protective effect of SQG on vascular endothelial function, as well as its effect on related clinical symptoms, risk factors, and the target organs of hypertension.
Trial Registration:
Chinese Clinical Trials Registry, ChiCTR1800016427. Registered on 1 June 2018.
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