The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
BMJ Open. 2023 May 10;13(5):e055263. doi: 10.1136/bmjopen-2021-055263.
Coronary heart disease(CHD) with stable angina pectoris is a common cardiovascular disease. It has been reported that 10%-81.4% of these patients suffer from psychological conditions,such as depression, which has been associated with more frequent angina, lower treatment satisfaction and lower perceived quality of life. extract (GBE), the raw material of dropping pills (GBDPs), is widely used to treat various conditions, including cardiovascular disease, ischaemic cerebrovascular disease, and depression. This clinical trial aimed to examine the efficacy and safety of GBDPs in improving the frequency of angina pectoris and the life quality of patients with stable angina pectoris and depression symptoms.
This randomised, double-blind, placebo-controlled, parallel-group and multicentre clinical trial will be conducted in four medical centres in China. We aim to recruit approximately 72 participants aged 18-75 years with depression and coronary heart disease with stable angina pectoris. Based on conventional drug treatment, participants will be randomly assignedto the treatment group (GBDPs group; n=36) or the control group (placebo group; n=36) at a 1:1 allocation ratio. After randomisation,follow-up will be done at 4 weeks, 8 weeks and 12 weeks (±3 days). Additionally, 30 healthy individuals will be enrolled to investigate the underlying pharmacological mechanisms of the effects of GBE. The primary outcomes will be the Seattle Angina Questionnaire score and the frequency of angina pectoris-related symptoms each week. The secondary outcomes will include the 36-item Short Form Health Survey quality-of-life scale, Hamilton Depression Scale and composite endpoint incidence of major adverse cardiovascular events.
This trial has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYECK [2020]030). Written informed consent will be obtained from all participants. The results of this trial will be publicly shared through academic conferences and peer-reviewed journals.
NCT04529148 and ChiCTR2200066908.
稳定性心绞痛合并冠心病是一种常见的心血管疾病。据报道，其中 10%-81.4%的患者存在心理状况，如抑郁，这与更频繁的心绞痛、更低的治疗满意度和更低的感知生活质量有关。银杏叶提取物（GBE）是滴丸（GBDPs）的原料，广泛用于治疗各种疾病，包括心血管疾病、缺血性脑血管疾病和抑郁症。本临床试验旨在研究 GBDPs 改善稳定性心绞痛伴抑郁症状患者心绞痛发作频率和生活质量的疗效和安全性。
本随机、双盲、安慰剂对照、平行分组和多中心临床试验将在中国的 4 家医疗中心进行。我们旨在招募约 72 名年龄在 18-75 岁之间的患有抑郁症和稳定性心绞痛的冠心病患者。基于常规药物治疗，参与者将按照 1:1 的比例随机分为治疗组（GBDPs 组；n=36）或对照组（安慰剂组；n=36）。随机分组后，将在 4 周、8 周和 12 周（±3 天）进行随访。此外，还将招募 30 名健康个体，以研究 GBE 作用的潜在药理学机制。主要结局指标为西雅图心绞痛问卷评分和每周心绞痛相关症状的频率。次要结局指标包括 36 项简短健康调查生活质量量表、汉密尔顿抑郁量表和主要不良心血管事件复合终点发生率。
本试验已获得中国广州中医药大学第一附属医院研究伦理委员会的批准（批准文号：ZYYECK[2020]030）。将从所有参与者处获得书面知情同意。本试验的结果将通过学术会议和同行评议期刊公开共享。
NCT04529148 和 ChiCTR2200066908。
