Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- HbA1c values
研究概览
简要总结
In patients with diabetes mellitus type 2 stably adjusted to diet long-term intake of aqueous-ethanolic extract from Hintonia latiflora over more than 12 months leads to a statstically significant amelioration of parameters of glycaemic control (HbA1c, postprandial and fasting glucose) not acchievable with diet alone.
As safety parameters, liver function tests and cardiovascular parameters are to be monitored. Adverse events are to be monitored.
详细描述
Objective:
To evaluate the long term effects of an aqueous-ethanolic extract from the bark of Hintonia latiflora (1:4.5, extraction medium 32% ethanol) in mild to moderate cases of type II diabetes, especially on parameters of glycaemic control and safety.
Research Design and Methods:
The trial was carried out as a controlled single-centre open study. 30 patients stably adjusted to diet were treated with the study medication (3 x 2 ml/day before meals) for up to 36 months. Efficacy parameters were HbA1c and fasting and postprandial serum glucose. As parameters for safety, liver function tests, cardiac functions and adverse events were assessed.
Results:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate Diabetes mellitus type 2 stable adjusted to diet
- •Minimum duration of diabetic complaints 1 year
- •Fasting serum glucose 7-14 mmol/l
- •HbA1c max. 12%
- •Written consent
排除标准
- •Hepatic impairment
- •Renal impairment
- •Pregnancy
结局指标
主要结局
HbA1c values
次要结局
- General vegetative symptoms
- Postprandial blood glucose
- Fasting blood glucose
- BMI
- Liver function tests (ALT, GGT, AP)
- Serum lipids (triglycerides, cholesterol, HDL cholesterol)
- Adverse drug reactions (narratives)
- Blood pressure (systolic/diastolic)