A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 发起方
- Millet Roux
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Hamilton anxiety scale score
研究概览
简要总结
Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.
详细描述
The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.
The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).
Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of generalized anxiety disorder
- •HAM-A scale > 17 and <30
排除标准
- •HAM-A scale > 30
- •Psychotherapy
研究组 & 干预措施
Passiflora, Anxiety Disorders
1 tablet Passiflora;Crataegus;Salix; PO;BID
干预措施: Passiflora (Drug)
Valeriane, Anxiety Disorder
1 tablet Valeriana officinalis, PO, BID
干预措施: Valeriana officinalis (Drug)
结局指标
主要结局
Hamilton anxiety scale score
时间窗: Four weeks
The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
次要结局
- Insomnia gravity index(Four weeks)
- Clinical global impression rate scale and Patient global evaluation rate scale(Four weeks)