Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Liver function
研究概览
简要总结
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks.
详细描述
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks. Satisfaction was assessed after 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age more than 18 years
- •No Diabetis mellitus disease and no taking diabetes medication
- •Blood sugar level less than 126 mg/dl and HbA1C less than 6.5
- •Can using Thai language
- •Willing to participate in the study
排除标准
- •Allergic to mulberry extract
- •Take mulberry extract in 2 weeks before participate in this study
- •Take medications that have effect on blood sugar level such as steroid in 2 weeks before participate in this study
- •Have uncontrolled disease
- •Have AST, ALT, ALP more than 3 times of normal value, or estimated Glomerular Filtration Rate less than 30 ml/min/1.73 m2)
- •Pregnancy or lactation
研究组 & 干预措施
Placebo group
They took the sample 3 times/day for 8 weeks.
干预措施: Placebo (Other)
Mulberry leaf extract capsule (DNJ 12mg) group
They took the sample 3 times/day for 8 weeks.
干预措施: Mulberry Leaf Extract (Combination Product)
结局指标
主要结局
Liver function
时间窗: 8 weeks
Aspartate transaminase (AST), Alanine aminotransferase (ALT), and Alkaline phosphatase (ALP) are in normal range.
Renal function
时间窗: 8 weeks
Blood urea nitrogen (BUN) and Creatinine are in normal range.
Complete blood counts
时间窗: 8 weeks
Complete blood counts are in normal range.
Adverse events
时间窗: 8 weeks
Adverse events are observed.
次要结局
- Blood glucose level(8 weeks)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University