Songling Xuemaikang Capsules for Cerebral Small Vessel Disease: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in the volume of white matter hyperintensities at 1 year.
研究概览
简要总结
Cerebral small vessel disease (CSVD) is a common age-related microvascular disease related to the slow accumulation of damage to small arteries, veins, and capillaries. Hypertension is a risk factor for cerebrovascular disease, and its damage to the vascular endothelium is one of the key contributing factors to the pathogenesis of CSVD. CSVD has an insidious onset, and patients may exhibit no clinical symptoms in the early stage. Common clinical manifestations of chronic CSVD include vascular dementia, depression, gait disturbance, and abnormalities in swallowing and urinary functions. There is currently no specific treatment for CSVD.
Existing studies have shown that Songling Xuemaikang capsule (SXC) combined with antihypertensive drugs exerted significant effects on systolic blood pressure (SBP), diastolic blood pressure (DBP), 24-hour SBP, and 24-hour DBP, while also improving symptoms of hypertension. Animal experiments have demonstrated that SXC can reduce apoptosis and alleviate cerebral ischemia-reperfusion injury, exerting neuroprotective effects. Additionally, a previously completed multicenter, randomized, double-blind, non-inferiority-designed clinical trial by the team, conducted in patients with primary hypertension, showed that SXC were non-inferior to losartan potassium in reducing diastolic blood pressure. Therefore, exploring the therapeutic potential of SXC in CSVD is highly necessary.
This project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of SXC in the treatment of hypertension with CSVD. A total of 90 subjects who met the subject screening criteria are planned to be enrolled, with 45 patients in the test group and 45 patients in the placebo group.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55-75 years (both inclusive);
- •MRI has moderate to (1) severe white matter lesions (deep Fazekas score > 1 or paraventricular Fazekas score > 2 or modified Fazekas score > 1), or (2) mild white matter hyperintensity (deep Fazekas score = 1 or paraventricular Fazekas score = 2 or modified Fazekas score = 1) combined with more than 1 lacunar infarction;
- •History of essential hypertension; Hypertension is defined as SBP consistently greater than 140 mmHg and/or DBP consistently greater than 90 mmHg, or those requiring clinical antihypertensive treatment.
- •Meeting the diagnostic criteria for hyperactivity of liver yang pattern; Hyperactivity of liver yang pattern is defined as having at least three of the following six symptoms: headache, dizziness or vertigo, irritability, flushed face, red eyes, and yellow tongue coating.
- •Functional independence in daily living (Modified Rankin Scale ≤2);
- •Voluntary participation in the study and be willing to sign the Informed Consent Form.
排除标准
- •Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months;
- •Symptomatic stenosis of the middle cerebral artery and/or internal carotid artery (stenosis rate ≥50%), or asymptomatic stenosis of the middle cerebral artery and/or internal carotid artery (stenosis rate ≥70%);
- •Untreated cerebrovascular malformations or intracranial aneurysms (diameter >3 mm);
- •Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);
- •Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.);
- •A history of intracranial or intramedullary surgery within the past year;
- •Severe hepatic, renal, or cardiac insufficiency (ALT or AST >2 times the upper limit of normal, or serum creatinine >1.5 times the upper limit of normal, or New York Heart Association [NYHA] functional class III or IV);
- •Severe three-vessel coronary artery disease as shown by coronary computed tomography angiography or coronary angiography within 90 days or suffering from frequent angina;
- •Refractory hyperglycemia uncontrolled by medication (fasting blood glucose >10 mmol/L, or HbA1c >8.0%);
- •Patients with severe diseases such as cancer and a life expectancy of less than 2 years;
- •Patients with psychiatric disorders that affect study medication administration and evaluation;
- •Previous allergy or intolerance to Songling Xuemaikang Capsules;
- •Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);
- •Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;
- •Participation in other clinical trial projects.
研究组 & 干预措施
Test group
Songling Xuemaikang Capsule, 3 capsules/time, tid, p.o
干预措施: Songling Xuemaikang Capsule (Drug)
Control group
Songling Xuemaikang Capsule placebo, 3 capsules/time, tid, p.o
干预措施: Songling Xuemaikang Capsule Placebo (Drug)
结局指标
主要结局
Changes in the volume of white matter hyperintensities at 1 year.
时间窗: 1 year
Measure changes in the volume of white matter hyperintensities on brain MRI
次要结局
- Change from baseline in Mini-Mental State Examination (MMSE) at 1 year;(1 year)
- Change from baseline in the mean 24h systolic blood pressure at 1 year;(1 year)
- Change from baseline in Hamilton Anxiety Scale (HAMA) at 1 year;(1 year)
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 1 year;(1 year)
- Change from baseline in Barthel Index (BI) at 1 year;(1 year)
- Change from baseline in the mean 24h pulse pressure at 1year(1 year)
- Change from baseline in the official diastolic blood pressure at 1 year(1 year)
- Change from baseline in Hamilton Depression Scale (HAMD) at 1 year;(1 year)
- Change from baseline in the official blood pressure compliance rate at 1 year(1 year)
- Feasibility of recruitment and retention(1 year)
- Change from baseline in the symptom of hyperactivity of liver yang pattern at 1 year;(1 year)
- Change from baseline in the mean 24h diastolic blood pressure at 1 year;(1 year)
- Change from baseline in the mean nighttime diastolic blood pressure at 1 year(1 year)
- Change from baseline in the blood pressure load at 1 year(1 year)
- Change from baseline in the mean daytime systolic blood pressure at 1 year;(1 year)
- Change from baseline in the mean daytime diastolic blood pressure at 1 year;(1 year)
- Change from baseline in the mean nighttime systolic blood pressure at 1 year(1 year)
- Change from baseline in the official systolic blood pressure at 1 year(1 year)
- Change from baseline in the official pulse pressure at 1year(1 year)
研究者
Ying Gao
Prof.
Dongzhimen Hospital, Beijing