Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improve glycated hemoglobin (HbA1c) value
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
详细描述
This trial is a randomized double-blind human trial, mainly to investigate the effect of long-term consumption of red yeast rice products on reducing glycated hemoglobin (HbA1c) and regulating blood sugar. It is expected to recruit 80 subjects for a period of 24 weeks. The test group takes 2 capsules of red yeast rice per day (Each capsule contains 440mg ANKASCIN 568-P), the control group took placebo capsules daily, blood samples were collected for biochemical analysis at 0, 4, 12, and 24 weeks, and the general body position measurement, blood pressure, Blood lipids, blood sugar and other related changes, and monitor liver, kidney, thyroid function.
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)
盲法说明
This experiment adopts a block random assignment design, and the system assignment table (Block randomization, block size = 6) randomly generated by the program is given serial numbers and assigned to groups. The probability of assignment to each group is 1/2.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women over 20 years old (women of childbearing age are not allowed to become pregnant or breastfeed during the study) adults who are sane and able to communicate.
- •Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
- •Blood glucose level measurement meets any of the following conditions:
- •(1) The fasting blood sugar is between 100∼125 mg/dL, and the doctor judges that there is no need to use hypoglycemic drugs for the time being.
- •(2) Or the glycosylated hemoglobin is between 5.7∼6.4%, and the doctor judges that the use of hypoglycemic drugs is not needed for the time being.
- •(3) Diabetic patients who have no willingness to take medicine and have not taken hypoglycemic drugs in the past month.
- •5. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
- •6. Hypoglycemic drugs are not allowed to be used during the trial. If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn.
- •7. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.
排除标准
- •Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
- •Moderate or severe liver and kidney dysfunction (generally refers to serum aminopyruvate converting enzyme (SGPT) and serum glutamate phenylacetate transaminase (SGOT) are more than 3 times higher than the upper limit of normal value or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
- •Pregnant or lactating women.
- •Diabetic patients taking hypoglycemic drugs or insulin injections.
- •Those who take traditional Chinese medicine mainly red yeast rice.
- •Have undergone surgery within one month.
- •Combined with serious diseases such as heart, liver, kidney and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, who do not eat the test samples according to the regulations, so that the efficacy cannot be judged or the incomplete data affect the judgment of efficacy or safety.
结局指标
主要结局
Improve glycated hemoglobin (HbA1c) value
时间窗: 24 weeks
After 24 weeks of taking red yeast rice capsules or placebo gel, whether there is a statistical difference between the test group and the placebo group in terms of improving the HbA1c value of glycosylated hemoglobin.
次要结局
未报告次要终点