Emotional Problem Clinical Trial
Official title:
Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Verified date | October 2022 |
Source | National Science Council, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | February 28, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. 21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview 2. At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics. 3. Understand the whole process of the study and had signed the informed consent form Exclusion Criteria: 1. 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. 2. Currently taking antidepressants or other medication that may impact the study. 3. Expected to be non-adherent. 4. Without sufficient data to confirm safety. 5. Pregnant woman 6. Allergic to fungal products. 7. Currently taking MAO-inhibitors |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
National Science Council, Taiwan | National Taiwan University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of subjective depressive symptoms | Measured by Beck Depression Inventory-II | 8 weeks | |
Primary | Change of objective depressive symptoms | Measured by Hamilton Rating Scale for Depression | 8 weeks | |
Primary | Change of somatic symptoms | 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. | 8 weeks | |
Primary | Cortisol level | Measured as a stress-related biomarker | 8 weeks |
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