The Clinical Safety of Alcoholic Extract Sahastara Remedy of Extract Capsule in Healthy Volunteers (Clinical Trial Phase I)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis
研究概览
简要总结
The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers. Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule in healthy volunteers. This is Clinical trial Phase I.
详细描述
The sahastara remedy (SHT) is a Thai traditional medicine that is use to relieve pain of musculoskeletal problem. There is study shown that SHT extract was not found acute and chronic toxicity in rat. However, there is no study regarding safety in human. Thus, this study is a clinical trial Phase I that investigate clinical safety of SHT alcoholic extract in healthy volunteers. The clinical safety will monitor for 28 days in continuously use of 100 and 200 mg SHT extraction 3 time a day and after stop intervention for 14 days.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No pregnancy
- •No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
- •No Supplementary food and/or Vitamin during the study
- •Able to follow suggestion during the study
排除标准
- •Uncontrolled Hypertension (BP>140/90 mm.Hg.)
- •BMI > 30
- •Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
- •On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
研究组 & 干预措施
100 mg SHT extract
The Sahastara remedy alcoholic extract capsule dose 100 mg.
干预措施: Sahastara remedy alcoholic extract (Drug)
200 mg SHT extract
The Sahastara remedy alcoholic extract capsule dose 200 mg.
干预措施: Sahastara remedy alcoholic extract (Drug)
结局指标
主要结局
Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis
时间窗: 14 days after stop intervention
Clinical safety was evaluated changing from baseline,14 days and 28 days while using intervention by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis
次要结局
未报告次要终点
研究者
Puritat Kanokkangsadal
Department of Applied Thai Traditional Medicine, Faculty of Medicine
Thammasat University