NCT02660593Unknown不适用
SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study
Shidaihuajing Institute for Diabetic Research2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Blood Sugar level
研究概览
简要总结
MedlinePlus related topics: Blood Sugar
Primary Outcome Measures:
- Fast glucose and HbA1c change between the baseline and end of study [ Time Frame: From baseline to 30 and 100 days]
- [ Designated as safety issue: No ]
- Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [ Time Frame: From baseline to 30 days and 100 days] [ Designated as safety issue: No ]
Secondary Outcome Measures:
• To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36 [ Time Frame: From baseline to month 1 ] [ Designated as safety issue: No ]
详细描述
This study is aimed to evaluate the safety and efficacy of Sangrow Decotion, diet and exercise for the treatment of type 2 diabetes. Previous study has shown that this therapeutic regimen is safe and effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus patients who have received medical treatment for more than 3 months
- •Patients willing to sign written informed consent form
排除标准
- •Patients unable or unwilling to comply with the requirements of the protocol
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Life expectancy < 6 months due to concomitant illnesses.
研究组 & 干预措施
SanGrow
Experimental
Patients will be given SanGrow Decoction 150 ml per day for 3 months.
干预措施: SanGrow Decoction (Dietary Supplement)
结局指标
主要结局
Blood Sugar level
时间窗: From baseline to 30 and 90 days
Fast glucose change between the baseline and end of study
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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