Quality Control and Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes of Hematology test
研究概览
简要总结
To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg for for 6 weeks. (Clinical Trial phase I)
详细描述
Sample size Group 1 (100mg/meal) = 6 female, 6 male Group 2 (200mg/meal) = 6 female, 6 male
Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals and the other take Prasaprohyai 95% ethanolic extract capsule at a dose of 200 mg 3 times a day before meals for six weeks. After that, they will cease using the drug for 2 weeks (wash out period). All volunteers will be followed up in the third week, sixth week and eighth week to evaluate the safety of the medicines. The researcher will record data such as age, career, BMI, vital signs, signs and symptoms. Safety will be monitored by hematology tests such as liver function test, renal function test, lipid profile and blood sugar.
The first step in this research will be to study group 1 (100 mg). If it proves safe, the group 2 (200 mg) will be studied.
The data gathered will be evaluated using statistical software. The results are in the form of mean ± standard deviation. The study will be planned as repeated measured ANOVA or Friedman's test in order to evaluate differences between groups, accompanied by using paired t-test or Wilcoxon's test in order to evaluate differences within groups. A significance level of p < 0.05 will be considered statistically significant.
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
- 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 in range 20-60 years old.
- •Healthy, or don't have serious medical conditions such as congestive heart disease, liver and renal dysfunction, uncontrolled hypertension, severe asthma, tuberculosis, HIV in the previous month before being recruited in the study, using history taking and complete physical examination and laboratory result.
- •Do not taking a medicine constantly.
- •Female not pregnant or lactating (non menopause woman will have a pregnancy test. Time since first day of last menstruation 28-35 days).
- •Participant and agreement to follow the instructions for 8 weeks.
- •Not a participant in another study.
排除标准
- •Allergic reactions to Prasaprohyai medications.
研究组 & 干预措施
group1
Group1 will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals (for 6 weeks)
干预措施: Prasaprohyai (Drug)
group2
Group2 will take Prasaprohyai 95% ethanolic extract capsules at a dose of 200 mg three times a day before meals (for 6 weeks)
干预措施: Prasaprohyai (Drug)
结局指标
主要结局
Changes of Hematology test
时间窗: week0, week3, week6 and week8
All volunteers will receive a hematology test to check renal function, liver function, lipid profile, glucose, complete blood count
次要结局
- Diary note(Everyday until week8 after took Prasaprohyai)
研究者
Miss Nichamon Mukkasombut
Principal Investigator
Thammasat University