NCT03492892已完成不适用
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- 24 hour ambulatory blood pressure
研究概览
简要总结
To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.
详细描述
Acupuncture has been widely used for blood pressure management. Its effect on the cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 45 and 75 years;
- •were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history;
- •without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases;
- •the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4;
- •didn't administer any drugs or herbs in at 15 days before the start of the study;
- •didn't participate in any study other than this;
- •agreed to cooperate with researchers in all research procedures after they were introduced this study; and
- •provided with written informed consent.
排除标准
- •age≤45 or age≥75;
- •with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension;
- •had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic;
- •accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.;
- •with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72);
- •pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year;
- •with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen;
- •with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders;
- •alcoholics or drug abusers, or vegetarians;
- •used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis;
- •used to administer any drug that may potentially impaired renal or hepatic function;
- •with cardiovascular disease that had been treated with acupuncture within recent three months; or
- •undergoing other clinical trials.
结局指标
主要结局
24 hour ambulatory blood pressure
时间窗: up to week 6
次要结局
- targeted plasma metabolome(up to week 6)
研究者
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