Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS - visual analogue scale
研究概览
简要总结
This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.
详细描述
This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product, under the Brazilian law for registration and revalidation RDC 14/2010.
AMARGOL® indications are for non specific digestive complaints as laxative and anti-dyspeptic.
Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum, Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.
Placebo controlled test
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-45 years old
- •healthy volunteers
排除标准
- •chronic dyspeptics illness chronic congestive cardiac problems
- •pulmonary problems
- •diabetes, thyroid problems
- •pregnancy
- •bowel syndrome
- •hemorrhoids
- •allergies for any formula components.
研究组 & 干预措施
AMARGOL
per oral solution 40 mL single dose
干预措施: AMARGOL® (Drug)
Vehicle without active principles
per oral solution 40 mL single dose
干预措施: AMARGOL® (Drug)
结局指标
主要结局
VAS - visual analogue scale
时间窗: 24h
Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal
次要结局
未报告次要终点