NCT06093932招募中4 期
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
Xiyuan Hospital of China Academy of Chinese Medical Sciences5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
研究概览
简要总结
The purpose of this study is:
- To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension.
- To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension.
- To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35-65 years old, male or female;
- •Grade 1 essential hypertension;
- •Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;
- •Sign the informed consent;
排除标准
- •Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR<60ml/(min·
- •Gastrointestinal diseases, which may affect drug absorption;
- •Be allergic to the clinical trial medicine;
- •Pregnant or breastfeeding women, men who plan to give birth within half a year;
- •Combined with other serious primary diseases or malignant tumors;
- •Hyperlipidemia with or without taking lipid-lowering drugs;
- •Combined with left ventricular hypertrophy, ABI < 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque;
- •Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes);
- •Other serious conditions in which is not fit for the study.
研究组 & 干预措施
Lifestyle intervention + Songling Xuemaikang Capsules
Experimental
- Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
- Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
干预措施: Songling Xuemaikang Capsules (Drug)
Lifestyle intervention + Songling Xuemaikang Capsules
Experimental
- Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
- Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
干预措施: Lifestyle intervention (Behavioral)
Lifestyle intervention + placebo
Placebo Comparator
- Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
- placebo, 3 capsules at a time, three times a day, duration: 12 weeks
干预措施: Lifestyle intervention (Behavioral)
Lifestyle intervention + placebo
Placebo Comparator
- Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
- placebo, 3 capsules at a time, three times a day, duration: 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
时间窗: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
次要结局
- Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the ba-PWV at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the skin capillary density(SCD) at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Mean 24h PP at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Official BP Compliance Rate at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Official PP at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Official DBP at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the BP load at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Official SBP at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Home SBP at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Home DBP at 4,12 weeks(Baseline and Week 4,12)
- Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks(Week 12)
- Change from Baseline in the CIMT at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks(Baseline and Week 4,12)
- Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks(Baseline and Week 4,12)
研究者
研究点 (5)
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