NCT05002634Unknown不适用
Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Aspartate aminotransferase value
研究概览
简要总结
This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. Liver function test, renal function test, and adverse event will be assessed.
详细描述
This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. Liver function test, renal function test, and adverse event will be assessed before and after taking for 1 and 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-60 years
- •No taking collagen supplement more than 2 weeks
- •No collagen and protein allergy
- •No liver and renal disease
- •Have a willingness to participate in the study
排除标准
- •Uncontrolled disease
- •Have complication symptom during study
- •Pregnancy or lactation
- •Cannot follow the protocol
- •During participated in other studies
结局指标
主要结局
Aspartate aminotransferase value
时间窗: 2 months
Aspartate aminotransferase value (U/L) in blood sample
次要结局
- Alkaline phosphatase value(2 months)
- Adverse event(2 months)
- Alanine transaminase value(2 months)
- Creatinine value(2 months)
- Blood urea nitrogen value(2 months)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
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