NCT02844803Unknown早期 1 期
Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Namyi Gu1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of serum glucose level after 8 weeks from baseline
研究概览
简要总结
The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as a diabetes mellitus patient at least 3 months ago on screening
- •Treated with metformin of ≥ 500 mg/day over 3 months on screening
- •Fasting glucose level of 110~180 mg/dl or HbA1c of 7.0~9.0% on screening
排除标准
- •With acute or chronic inflammation
- •Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication
- •With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases
- •With acute or chronic renal failure or nephrotic syndrome
- •With impaired hepatic function.
- •Drug or Alcoholic abuser
- •Pregnant or nursing woman
研究组 & 干预措施
Active drug-> Placebo
Other
Metformin + S. Baicalensis --> Metformin + Placebo
干预措施: Combination of Metformin + S. Baicalensis (Drug)
Active drug-> Placebo
Other
Metformin + S. Baicalensis --> Metformin + Placebo
干预措施: Combination of Metformin + Placebo (Drug)
Placebo -> Active drug
Other
Metformin + Placebo --> Metformin + S. Baicalensis
干预措施: Combination of Metformin + S. Baicalensis (Drug)
Placebo -> Active drug
Other
Metformin + Placebo --> Metformin + S. Baicalensis
干预措施: Combination of Metformin + Placebo (Drug)
结局指标
主要结局
Change of serum glucose level after 8 weeks from baseline
时间窗: Day1 and Day 57 on the 1st and 2nd periods
次要结局
未报告次要终点
研究者
Namyi Gu
Assistant professor
DongGuk University
研究点 (1)
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