Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Body Temperature
研究概览
简要总结
Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.
This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5 without any signs of infections will be enrolled in this study. Patients will be randomly divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group will receive placebo twice daily.
详细描述
Patients in each group will be monitored for body temperature at baseline (at the time of enrollment) and at 1, 2, 4, 6, 8, 24 h after receiving the tested material.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •Body temperature between 37.8-38.5
- •Body weight not less than 40 kg but not over 100 kg
- •Liver enzymes do not exceed 2 times of normal value
- •Can comply with study protocol
排除标准
- •Have allergic history of any tested compounds
- •Fever from other causes, not by URI
- •Take any herbal medicines during 2 weeks before enrollment
- •Physicians decide to withdraw the subjects with any reasons
研究组 & 干预措施
Acetaminophen
Acetaminophen administer 1000 mg every 4-6 hours when fever is presented
干预措施: Acetaminophen (Drug)
Tinospora Crispa-extract Product
Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented
干预措施: Tinospora Crispa-extract Product (Drug)
Placebo
Placebo 2 tablets will be administered every 4 hours when fever is presented
干预措施: Placebo (Other)
结局指标
主要结局
Body Temperature
时间窗: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours
次要结局
- Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine(Participants will be followed for the duration of hospital stay (24 hours))
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Associate Professor
Chulalongkorn University