CTRI/2009/091/000702已完成2 期
A clinical study of a herbal formulation 'Diabeat' as an adjuvant drug for the control of type 2 diabetes mellitus
Hamdard National Foundation New DElhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean HbA1C 6.5%
研究概览
简要总结
This study is a randomized, double blind parallel group, trial comparing the safety and efficacy of 'Diabeat'(1gram twice daily) plus standard drug(Metformin SR-500 mgtwice daily)with placebo (1gram twice daily)plus standard drug(Metformin SR-500mg twice daily)in 100 patients of Type 2 diabetes mellitus that will be conducted in Majeedia Hospital,New Delhi. The primary outcome measures will be To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl,Time point:4,8,12 weeks . The secondary outcome will be Mean HbA1C< 6.5%, Time point: 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of type-2 diabetes mellitus, age 30-60 years taking Metformin for more than 3 months with uncontrolled hyperglycaemia i.e.HbA1C between 7% to 9% and Body Mass Index (BMI) between 25-29.9 kg/m
- •Patients who are able and willing to follow anti-diabetic therapy under a stable life style and diabetic diet.
- •3.Patients who are willing and able to understand and follow the protocol and provide informed consent.
排除标准
- •1.History of treatment with any insulin 2.Diabetes mellitus with complications 3.Pregnant or Lactating women 4.Women of childbearing potential who do not take adequate contraceptive protection.
- •5.History of hypersensitivity to the Metformin or to drug with similar chemical structure.
- •6.History of any severe systemic disease.
- •7.Patients with uncontrolled hypertension.
- •8.History of drug or alcohol abuse.
结局指标
主要结局
Mean HbA1C 6.5%
时间窗: 12 weeks
次要结局
- To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl)(4,8,12 week)
研究者
研究点 (1)
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