NCT00944268Unknown3 期
Clinical Study Phase III, Multicenter, Prospective, Open to Evaluate the Efficacy and Tolerability of the Combination Use of Passiflora Incarnata L, Crataegus Oxyacantha and Salix Alba L in Mild and Moderate Anxiety
Ativus Farmaceutica Ltda1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Hamilton Scales
研究概览
简要总结
To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.
Clinical study phase III, multicenter, prospective, open.
Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;
- •Individuals of any ethnic group male and female, aged above 18 years;
- •Consent of the subject of research (a consent form signed).
排除标准
- •Patients with known hypersensitivity to any components of the formula;
- •Pregnant women and nursing mothers;
- •Patients with endogenous depression, schizophrenia, suicidal tendency;
- •Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;
- •Addiction to drugs, including alcohol, at the discretion of the investigator;
- •Patients who are using any medication that could interfere with the effect of the drug under study;
- •Impossibility of compliance to the protocol
研究组 & 干预措施
Liquid and solid
Experimental
干预措施: Passiflora, Crataegus e Salix (Drug)
结局指标
主要结局
Hamilton Scales
时间窗: 30 days
次要结局
- Safety evaluation by adverse events relate.(30 days)
研究者
研究点 (1)
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