The Effects of Trichosanthes Root on Blood Sugar in Patients With Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin A1c
研究概览
简要总结
Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen, According to traditional Chinese writing record that Trichosanthes root has the action of downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes root may lower blood sugar levels in the modern study. The investigators designed a double blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar were divided into treatment and control groups, and each group was 30 patients. In the treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g, bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root treatment. The investigators predict the results of the present study indicated that Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early diagnosis Type Ⅱ Diabetic patients who Glycated hemoglobin A1c level between 7.0% and 9.0% (including) , and after three months of diet and exercise control.
- •The subject who was taking hypoglycemic drugs Metformin, the maximum total amount of ≦ 1500 mg / day.
- •Age ranged between 20 and 80 years (including).
排除标准
- •Pregnancy or breast-finding.
- •Allergy to test medicine.
- •Type I Diabetic patients.
- •Bleeding tendency.
- •The participants who suffered from serious disorders, such as congestive heart failure, myocardial infarction, chronic obstructive pulmonary disease, renal failure, cancer or stroke etc.
- •Irritable or anxious patients who cannot be assessed.
- •Refuse to sign the agreement.
- •The values of SGOT and SGPT levels were more than normal limit triple, or the value of creatinine level was more than normal limit.
- •Plasm glucose(Glucose AC) level in fasting state ≧ 300 mg / dL.
研究组 & 干预措施
Trichosanthes root
Trichosanthes root at a rate of 1.5 g two times per day for 84 days.
干预措施: Trichosanthes root (Drug)
Placebo
Trichosanthes root at a rate of 0.15g (10%) two times per day for 84 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Glycated hemoglobin A1c
时间窗: Three months
Improvement of glycated hemoglobin A1c levels
Plasma Blood Sugar
时间窗: Three months
Improvement of Plasma Blood Sugar levels
次要结局
未报告次要终点