CTRI/2010/091/006099已完成2 期
An open label, multi centric study to investigate the safety, tolerability and anti-hyperglycemic effects of a herbal medicine ?ADM01 Tablets? as an add-on therapy in Type 2/ Non-Insulin Dependent Diabetes Mellitus Patients.
Phyto Health Pharma B.V.P. O. Box 14, 2280AA Rijswijk, The NetherlandsTel: 0031 (0)70 300 2467Fax: 0031 (0)70 396 41470 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •?Patients with Type 2 diabetes mellitus (according to the American Diabetes Association criteria 2004).
- •?Patients with HbA1c 7-11 %
- •?Patients taking any stable daily dosage of oral hypoglycaemic agent (not more than 75 % of recommended maximal dose) for at least three months.
- •?Age between 20 and 70 years.
- •?Body Mass Index between 20 and 35 kg/m2.
- •?Patients willing to give written Informed consent and come for regular follow up.
排除标准
- •?Patients with type 2 diabetes who are difficult to control with respect to glucose homeostasis (non-stable patients), which will be decided by Investigator on clinical history of patients.
- •?Patients who, in addition to the oral anti hyperglycaemic drug also require insulin
- •?Patients who can be controlled by a changed life style (e.g. exercise, reduced body weight)
- •?Moderate or severe alcohol use (> than two drinks containing alcohol per day)
- •?Smoking more than 10 cigarettes per day
- •?Pregnant and nursing women
- •?Diabetic complications requiring treatment
- •?Serious hepatic or renal impairment
- •?Heart failure corresponding to NYHA class III or IV
- •?Known hypersensitivity or allergy to one or more of the herbal ingredients
- •?Recent (< 1 month) participation in a clinical trial
- •?Recent (< 1 month) use of any herbal/ayurvedic anti-diabetic drugs
- •?Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, a history of ischemic heart disease, history of stroke and/or TIA
- •?Debilitating neurological or psychiatric disorders
- •?Any condition likely to hinder the compliance with the protocol.
研究者
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