Chamomile Therapy for Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Score on Hamilton Anxiety Rating Scale
研究概览
简要总结
This study will determine the effectiveness of chamomile extract for treating generalized anxiety disorder.
Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to placebo. 2)Chamomile will have a comparable safety profile to that of placebo.
详细描述
We propose to investigate the anti-anxiety activity of Chamomile. Among the many uses of Chamomile, its use as an anti-anxiety herb is universal. Despite its widespread use and acceptance, there have been no studies evaluating the safety and anti-anxiety efficacy of Chamomile in human subjects. Given this lack of controlled clinical data, we propose a pilot study of Chamomile safety and efficacy in mild anxiety, and propose using the data as a basis for statistically powering a future R01 application. We will ask: Is Chamomile a safe and effective alternative treatment for Generalized Anxiety Disorder (GAD)? To do this, 60 patients with a diagnosis of mild to moderate GAD will receive double-blind treatment for 8 weeks with either (i) Chamomile extract, or (ii) placebo. We hypothesize that Chamomile will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo.
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, Investigator, Outcomes Assessor)
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
- •Men and women > 18 years of age (all races and ethnicity)
- •Meet DSM IV criteria for GAD
- •Mild to moderate symptom severity
- •HAM-A score > 8
- •Not receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)
- •Able to understand and provide signed informed consent
- •Able to participate in a 8-week study
排除标准
- •Patients < 18 years old
- •Current DSM IV Axis I diagnosis of Major Depressive Disorder, Bipolar Disorder, Panic Disorder (with or without agoraphobia), Specific Phobia Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder, Substance-Induced Anxiety Disorder, Schizophrenia, Other psychotic disorders, Current alcohol or drug abuse, Alcohol or drug dependence within 3 months, [NB: Patients with co-morbid DSM IV Axis I Depressive Disorders NOS (e.g., minor depressive disorder, premenstrual dysphoric disorder, and recurrent brief depressive disorder will not be excluded)]
- •Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)
- •Allergy to Chamomile preparation
- •Allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)
- •Allergy to mugwort, RAST, or birch tree pollen
- •Concurrent tranquilizer, antidepressant or mood stabilizer therapy
- •Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., Chamomile, St. John's Wort, Kava kava)
- •Women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)
研究组 & 干预措施
2
Anxiolytic Therapy
干预措施: Placebo (Other)
1
Chamomile Extract
干预措施: Chamomile Extract (Dietary Supplement)
结局指标
主要结局
Score on Hamilton Anxiety Rating Scale
时间窗: 8 Weeks
次要结局
- Beck Anxiety Index Rating(8 Weeks)