Double Blind, Randomized Study, Controlled by Valeriana Officinalis, of Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Patients With Mild and Moderate Anxiety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Hamilton anxiety scale
研究概览
简要总结
Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be followed by a post treatment visit.
Hamilton anxiety scale will be used to assess anxiety.
详细描述
Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to treat anxiety disorders. This study will compare the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150 participants will be randomly assigned to receive the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post treatment visit will be done 2 weeks for safety evaluation.
Primary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index, Global clinical impression and patients global evaluation scales.
Side effects will be monitorized throughout the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •generalized anxiety disorder
- •HAM-A scale < 17 and > 30
排除标准
- •hypersensibility to any component
- •patients with depression, schizophrenia ou suicidal ideas
- •pregnant ou lactating
- •heart, liver, lung or kidney important condition
- •use of digitalis, AAS, anticoagulants agents, drugs with sedative or antidepressant action
- •psychotherapy
- •drug or alcohol dependence
- •gastrointestinal ulcer history
- •hyperthyroidism
- •neoplasia
- •coagulation disorders
研究组 & 干预措施
1
Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
干预措施: Passiflora ; Crataegus and Salix (Drug)
2
Valeriana officinalis 50 mg
干预措施: Valeriana (Drug)
结局指标
主要结局
Hamilton anxiety scale
时间窗: 6 weeks
次要结局
- Insomnia gravity index; global clinical impression; patients global evaluation(6 weeks)