The Effect of Saffron (Crocus Satious L.) in the Treatment of Mild to Moderate Generalized Anxiety Disorder: a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Hamilton anxiety score
研究概览
简要总结
anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus satious L.) in the treatment of mild to moderate generalized anxiety disorder:
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25
排除标准
- •pregnancy and lactation
- •receiving antipsychotic medications in a month prior to the recruitment
- •suffered from other psychological disorders (e.g. bipolar disorder, schizophrenia, mood disorders), and drug abuse
研究组 & 干预措施
saffron
450 mg of saffron capsule once a day for 6 weeks
干预措施: Saffron (Dietary Supplement)
placebo
placebo capsule once a day for 6 weeks
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Hamilton anxiety score
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
Dr Azita Hekmatdoost
National Nutrition and Food Technology Institute