Phase 0 Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Fasting blood glucose (FBG)
研究概览
简要总结
The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo.
详细描述
In China, the herbal formulas have been used in the treatment of diabetes for centuries. Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders.
This randomized, double-blind, placebo-controlled trial was conducted in a community hospital of Shanghai, China. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). During 3-month treatment, participants were randomly divided in to two groups assigned to take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight (BMI >= 20) or
- •Hyperglycemia (FBG>=6.7 mmol/l) or
- •Hyperlipidemia (TG >=1.7 mmol/l or TCH>=5.72 mmol/l or HDL-c <=1.00 mmol/l or LDL-c>=3.12 mmol/l)
排除标准
- 未提供
研究组 & 干预措施
AMP-1915
Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months.
干预措施: AMP-1915 (Drug)
Placebo
Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months.
干预措施: Placebo (Other)
结局指标
主要结局
Fasting blood glucose (FBG)
时间窗: Change from baseline FBG at 3 months
Patients' FBG from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment. The difference between these two time points presents the drug effect.
次要结局
- Plasma HbA1c(Change from baseline Plasma HbA1c at 3 months)
- Body weight(Change from baseline body weight at 3 months)
- Plasma lipid levels(Change from baseline lipid levels at 3 months)
- Plasma Insulin concentration(Change from baseline insulin concentration at 3 months)