Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The decline glycosylated hemoglobin A1C and blood glucose level
研究概览
简要总结
Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.
aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus.
---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes
详细描述
Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning Tongluo capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
- •Age between 18-70 years.
- •The blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/L, ≤ 13 mmol/L and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/L, ≤ 16 mmol/L; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%.
- •Traditional Chinese medicine symptom score ≥ 4 points.
- •Participated in the experiment voluntarily, and signed the informed consent form.
排除标准
- •Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
- •Secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, Bernard Glenn Nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional Chinese medicine.
- •Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
- •ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
- •Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
- •Pregnant, lactating women and prepare for pregnancy.
- •The allergic constitution and the drug allergy known composition.
- •For nearly a month with severe infection or other emergency state, such as trauma, operation etc..
- •within the past 3 months, participated in the other drugs.
研究组 & 干预措施
TNTL capsule and Placebo
3-4 capsules 3 times a day Used before meals
干预措施: TNTL capsule (Drug)
TNTL capsule and Placebo
3-4 capsules 3 times a day Used before meals
干预措施: Placebo (Drug)
结局指标
主要结局
The decline glycosylated hemoglobin A1C and blood glucose level
时间窗: up to 8 weeks
Decline in Hemoglobin A1C and blood glucose level
次要结局
- The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants(2 months)