A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
研究概览
简要总结
DBcare is a herbal food supplement that has been used over the years in India as a "traditional"anti-diabetic formula.DBcare was not tested controlled trials in humans, yet.We intend to test the ability of DBCare to improve blood sugar level control in patients with uncontrolled diabetes.
详细描述
Study design: prospective, randomized, single-blind, placebo-controlled trial
Inclusion criteria:
Men and women (older than 18 years old) with type 2 diabetes and inadequate glycemic control, defined by HbA1C 8% ³ £10%.
Previous medications include any oral hypoglycemic agents, as monotherapy or in combination.
Concurrent lipid-lowering, anti-hypertensive and other medications are allowed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18y
- •With type 2 diabetes mellitus and inadequate glycemic control
- •HBA1C >8 <10
- •Previous medications include oral hypoglycemic medications,as monotherapy or in combination
排除标准
- •Type 1 diabetes mellitus
- •Pregnant or lactating women
- •Insulin treatment 3 months prior to study entry
- •Creatinine >2
- •Abnormal liver function test GOT>2 or GPT>2 the upper limit of norm
- •Unstable anginal syndrome
- •Congestive heart failure NYHA 1-4
- •Inability to follow study instructions
结局指标
主要结局
Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
时间窗: 3 months
Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo
时间窗: 3 months
次要结局
- Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline(3 months)