NCT00940251已完成2 期
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- antidiabetic activity
研究概览
简要总结
To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Secondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c levels > 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day.
排除标准
- •Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency
研究组 & 干预措施
CORN STARCH
Placebo Comparator
干预措施: Mersina (Drug)
Mersina, Diet and exercise
Active Comparator
干预措施: Mersina (Drug)
结局指标
主要结局
antidiabetic activity
时间窗: 3 months
次要结局
- Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile(3 months)
研究者
研究点 (1)
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