NCT04897126已完成4 期
Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes of Seattle angina pectoris scale
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while the experimental group was treated with MUSK Pill 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age was 18-75 years old, and the gender was not limited;
- •The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), Within 1 year, coronary CTA or coronary angiography examination of coronary artery normal or lesions < 50%;
- •Willing to follow up and sign informed consent.
排除标准
- •Patients were selected and had no angina pectoris without medication
- •History of vascular reconstruction within 6 months, CABG or PCI;
- •Preparation for CABG or PCI during the trial period
- •The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination;
- •Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism;
- •There were three months of acute myocardial infarction;
- •Severe respiratory disease, COPD or active pulmonary infection;
- •Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period;
- •Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr > 1.5 times of normal value), active liver disease, cirrhosis or uremia patients;
- •Any other serious diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness;
- •Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies;
- •Pregnant, lactating women and women and men with recent birth plans;
- •Allergic constitution or allergy to known components of the study drug;
- •The researchers judged that the patients who were not suitable for the study were not suitable.
- •(Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)
研究组 & 干预措施
Experimental group
Active Comparator
The experimental group was treated with Shexiang Baoxin pill（MUSKARDIA） (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up
干预措施: Shexiang Baoxin pill（MUSKARDIA） (Radiation)
Placebo group
Placebo Comparator
The control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.
干预措施: Placebo (Radiation)
结局指标
主要结局
Changes of Seattle angina pectoris scale
时间窗: 12 weeks ± 1 week
Main evaluation indicators
次要结局
- Changes of angina pectoris classification in CCS(12 weeks ± 1 week)
- Incidence of major cardiovascular events (MACE)(12 weeks ± 1 week)
- the incremental cost-effectiveness ratio (ICER) was used as the evaluation index(12 weeks ± 1 week)
- Average number of angina attacks per week(12 weeks ± 1 week)
- Changes in total dosage of sublingual nitroglycerin buccal tablets(12 weeks ± 1 week)
研究者
研究点 (1)
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