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临床试验/NCT01844050
NCT01844050已完成不适用

Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Change from Baseline Total score of diabetes symptoms at 4 weeks

研究概览

简要总结

Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
  • After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l<2h PG<16mmol/l
  • Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
  • Subject is willing to participate and capable of giving informed consent.

排除标准

  • Those patients used any drugs for treatment of diabetes within one month.
  • Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
  • Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
  • Women who were pregnant, lactating or planned pregnant.
  • Allergic constitution and has a history of drug allergy.
  • Combined with severe acute or chronic infections.

研究组 & 干预措施

Chinese herbal medicine

Experimental

Individualized Treatment with Chinese herbal

干预措施: Chinese herbal medicine (Drug)

Placebo

Placebo Comparator

Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.

干预措施: Placebo (Drug)

结局指标

主要结局

Change from Baseline Total score of diabetes symptoms at 4 weeks

时间窗: 0 weeks(baseline), 2 weeks, 4 weeks

次要结局

  • Change from Baseline blood glucose at 2 hours after meal at 4 weeks(0 weeks(baseline), 2 weeks, 4 weeks)
  • Change from Baseline Fasting Blood Glucose at 4 weeks(0 weeks(baseline), 2 weeks, 4 weeks)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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