Development of Green Mei Products for the Prevention of Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change the blood pressure after intervention
研究概览
简要总结
The aim of this study is to investigate the antihypertensive effects of Mei-Gin formula-4 (MGF-4) and Mei-Gin formula-7.
详细描述
It's a randomized, and single-blind trial and was designed to evaluate the effects of MGFs (MGF-4 and MGF-4) on blood pressure. 50 participants with hypertension (systolic blood pressure between 130-179 mmHg or diastolic blood pressure between 85-109 mmHg) who did not accept any hypertension medication were randomized allocated to either MGF-4 or MGF-7 group. Participants were instructed to take 4 capsules of MGF-4 or MGF-7 daily throughout the duration of the 8 weeks intervention study. After treatment, the change of the blood pressure and relative mechanism were analyzed.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age of the subject is 20 to 70 years old.
- •The subject is a patient with hypertension (SBP is between 130-179 mmHg, DBP is between 85-109mmHg, one of the two can be diagnosed), and there are no serious illnesses requiring hospitalization during the study period treatment.
- •No hypertension medication.
- •The subject can understand the test process described in the consent form and the possible potential risks and benefits, and able to sign the consent form.
- •The subjects shall observe diet control during the trial period.
排除标准
- •Subjects diagnosed with cancer and still under active treatment.
- •Subjects diagnosed with heart disease and still under active treatment.
- •Other drugs are used, whose pharmacological effects may affect blood pressure or may aggravate the effects of drugs.
- •Subjects who have systemic infection and need systemic antibiotics.
结局指标
主要结局
Change the blood pressure after intervention
时间窗: Week 0, 4 and 8
Compare the difference of own SBP and DBP between the week 0, 4 and 8 in each groups
次要结局
- Change from baseline serum MDA and TEAC at Week 8(Week 0 and 8)