Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change of objective depressive symptoms
研究概览
简要总结
Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease.
Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview
- •At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics.
- •Understand the whole process of the study and had signed the informed consent form
排除标准
- •Had been diagnosed with severe mental disorder, schizophrenia, bipolar disorder, personality disorder, substance use disorder or alcohol use disorder, or other severe physical illness that is not expected to survive during the intervention period.
- •Currently taking antidepressants or other medication that may impact the study.
- •Expected to be non-adherent.
- •Without sufficient data to confirm safety.
- •Pregnant woman
- •Allergic to fungal products.
- •Currently taking MAO-inhibitors
结局指标
主要结局
Change of objective depressive symptoms
时间窗: 8 weeks
Measured by Hamilton Rating Scale for Depression
Change of subjective depressive symptoms
时间窗: 8 weeks
Measured by Beck Depression Inventory-II
Change of somatic symptoms
时间窗: 8 weeks
Measured by Neurotoxicity Rating Scale, a 39-item self-report scale to evaluate the somatic symptoms such as anorexia, fatigue and pain; higher scores indicate higher severity.
Cortisol level
时间窗: 8 weeks
Measured as a stress-related biomarker
次要结局
未报告次要终点
研究者
Kuan-Pin
Principal Investigator
National Science and Technology Council, Taiwan