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Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 2: 422 - 429

DOI: https://doi.org/10.19852/j.cnki.jtcm.2025.02.010

Original articles

Clinical efficacy of Angong Jiangya pill (安宫降压丸) for grade 2 hypertension with liver-fire hyperactivity syndrome: a randomized, double-blind, placebo-controlled, multicenter trial

  • Xiaolei LAI ,
  • Juju SHANG ,
  • Hongxu LIU ,
  • Jing HU ,
  • Xiang LI ,
  • Zhenmin ZHANG ,
  • Wenlong XING
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  • 1 Department of Cardiovascular, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
    2 Beijing Institute of Traditional Chinese Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China

Received date: 2023-12-22

  Accepted date: 2024-05-15

  Online published: 2025-03-10

Supported by

Program of Discipline Backbone of high-level Public Health Talents of Beijing Municipal Health Commission: Epidemiological Survey of Acute Myocardial Infarction Inpatients in Hospital of Traditional Chinese Medicine in Beijing Area(Discipline backbone-02-25);Beijing Municipal Hospital Administration Green Seedling Talent Project: Study on Characteristics of Clinical Syndromes, Status of Traditional Chinese Medicine Treatment and Prognosis of Patients with Chronic Heart Failure in Traditional Chinese Medicine Regional Health Service Center(QML20231006)

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Abstract

OBJECTIVE: To investigate the efficacy and safety of Angong Jiangya pill (AGJY, 安宫降压丸) in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.

METHODS: This multicenter, randomized, double-blind, placebo-controlled trial was conducted in eight medical institutions. Eligible patients with grade 2 hypertension were randomly allocated to receive AGJY or a placebo for 12 weeks. The primary outcome was the change in blood pressure (BP). The secondary outcomes were BP compliance rate, Traditional Chinese Medicine (TCM) symptoms, and Duchenne Hypertension Quality of Life Scale score.

RESULTS: Data were analyzed for 117 participants in the AGJY group and 118 participants in the placebo group. After 12 weeks of treatment, AGJY compared with placebo resulted in a higher and significant reduction in systolic/diastolic BP (－15.58 ± 10.16/－9.72 ± 7.41 vs －8.13 ± 8.28/－4.86 ± 5.68 mm Hg, P < 0.0001, < 0.0001, respectively). BP compliance rate (31.86% vs 19.13%, P= 0.027) was significantly higher in the AGJY group than in the placebo group. The AGJY group showed a significant reduction in TCM symptom score compared with the placebo group (10.82 ± 2.03 vs 7.83 ± 1.24, P< 0.0001). Single TCM syndrome clinical control rates of the primary symptoms (dizziness, headache, and irritability) were superior in the AGJY group (71.95%, 94.62%, 72.53%, respectively) compared with the placebo group (48.39%, 68.00%, 30.52%, respectively). Scores on the Duchenne Hypertension Quality of Life Scale showed a significant increase in the AGJY group compared with the placebo group (30.65 ± 21.06 vs 9.96 ± 10.72, P= 0.000). No serious adverse events occurred.

CONCLUSION: AGJY demonstrated efficacy in lowering BP, increasing the rate of BP compliance, and improving TCM symptoms and quality of life in patients with grade 2 hypertension liver-fire hyperactivity syndrome. However, further in-depth studies are required to determine the mechanism of TCM in treating hypertension.

Key words： hypertension; multicenter study; randomized controlled trial; liver-fire hyperactivity syndrome; Angong Jiangya

Cite this article

Xiaolei LAI , Juju SHANG , Hongxu LIU , Jing HU , Xiang LI , Zhenmin ZHANG , Wenlong XING . Clinical efficacy of Angong Jiangya pill (安宫降压丸) for grade 2 hypertension with liver-fire hyperactivity syndrome: a randomized, double-blind, placebo-controlled, multicenter trial[J]. Journal of Traditional Chinese Medicine, 2025 , 45(2) : 422 -429 . DOI: 10.19852/j.cnki.jtcm.2025.02.010

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