A Pilot Trial on Efficacy and Safety of a Formula Salt With Very Low Sodium (Manlikang) in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension in Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- the change of systolic pressure
研究概览
简要总结
This study is a single arm trial with before-after comparison design. Three groups of patients with hypertension will be recruited: not taking antihypertension drugs and having normal renal function, taking antihypertension drugs and having normal renal function, and having abnormal renal function without regards of antihypertension drugs use. Each group includes 30 patients. Based on renal function test, the investigators provide the Manlikang containing potassium chloride to patients with normal renal function, and provide the Manlikang not containing potassium chloride to patients with abnormal renal function. All hypertension patients will use the formula salt with very low sodium (Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks. The primary outcome will be the decrease of patients' systolic blood pressure at the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 75 years old
- •No planning to move out of the community in the next three months
- •Not cooking at home less than 3 times or one day during the study
- •Willing to participate in the study and sign informed consent
排除标准
- •Acute myocardial infarction, history of stroke in the past 3 months, history of malignancy or expected lifetime less than 1 year.
- •Hypercortisolism or aldosteronism
- •Acute disease, such as upper respiratory infection, fever and diarrhea.
- •Incapable of communicating, such as deaf and dumb, dementia, mental disorder.
- •Families taking salt substitute currently
- •Not willing to use Manlikang in family
- •Liver disfunction
- •Anyone with abnormal serum potassium in family
- •Anyone using potassium-retaining diuretics in family
结局指标
主要结局
the change of systolic pressure
时间窗: baseline and 6 weeks
the change of systolic pressure before and after taking Manlikang
次要结局
- incidence of reducing antihypertensive drug dose(up to 6 weeks)
- adverse event(up to 6 weeks)
- the change in 24-hour urine sodium(baseline and 6 weeks)
- incidence of reaching the normal blood pressure(up to 6 weeks)
研究者
Yangfeng Wu
director
Peking University