NCT04438486Unknown不适用
Effects of Barley Green in Patients With Hyperuricemia
Second Affiliated Hospital, School of Medicine, Zhejiang University7 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 7
- 主要终点
- uric acid level
研究概览
简要总结
This experiment evaluates the effect of Barley Green in patients with hyperuricemia ， and explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids, blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm B will receive dietary guidance and Barley Green.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old those who are willing to accept assessment and sign informed consent.
- •Under the normal purine diet, two fasting blood uric acid levels on different days: 420umol/l <blood uric acid <540 umol/l (male), 360 umol/l <blood uric acid <540 umol/l (female)
排除标准
- •Patients currently receiving treatment for hyperuricemia；
- •Suffering from diseases that affect the digestion and absorption(such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcers, after gastrointestinal resection, cholecystitis/cholecystectomy, etc.)；
- •Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases;
- •At the same time receive other functional food nutrition support (plant active substances, health food);
- •Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal renal function (serum creatinine exceeds the upper limit of normal value)；
- •Suffering from infectious diseases such as active tuberculosis and AIDS;
- •People who are severely allergic to the ingredients of research；
- •During pregnancy or lactation;
- •Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, suffering from serious diseases not included in the discharge criteria)；
- •Gouty arthritis attack ≥ 2 times;
- •One episode of gouty arthritis with blood uric acid >480 umol/l, or any of the following: age <40 years old, evidence of gout stone or urate deposition in the joint cavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency;
- •Blood uric acid>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.
结局指标
主要结局
uric acid level
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (7)
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