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Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002219
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
National Taiwan University
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Inflammation, Brain Emotional Problem Dietary Supplement: beverage containing mushroom-extracts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A triple-blind, randomized-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Active arm
Subjects will receive treatment with active beverage containing the active ingredient
Dietary Supplement: beverage containing mushroom-extracts
Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.

Placebo Comparator: Placebo arm
Subjects will receive treatment with placebo beverage not containing the active ingredient
Dietary Supplement: beverage containing mushroom-extracts
Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.




Primary Outcome Measures :
  1. Change of subjective depressive symptoms [ Time Frame: 8 weeks ]
    Measured by Beck Depression Inventory-II

  2. Change of objective depressive symptoms [ Time Frame: 8 weeks ]
    Measured by Hamilton Rating Scale for Depression

  3. Change of somatic symptoms [ Time Frame: 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.

  4. Cortisol level [ Time Frame: 8 weeks ]
    Measured as a stress-related biomarker



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002219


Contacts
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Contact: Kuan-Pin Su, MD, PhD 04-22052121 ext 4126 cobolsu@gmail.com
Contact: Ta-Wei Guu, MD 04-22052121 ext 4126 da20vid@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Yi Ju Chiang, Master    886-4-22062121 ext 2012    jill981206@gmail.com   
Principal Investigator: Kuan-Pin Su, MD PhD         
Principal Investigator: Ta-wei Guu, MD         
Sponsors and Collaborators
National Science Council, Taiwan
National Taiwan University
Investigators
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Study Director: Kuan-Pin Su, MD, PhD China Medical University, China
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Responsible Party: Kuan-Pin, Principal Investigator, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT04002219    
Other Study ID Numbers: CMUH108-REC3-022
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study has not yet fully discuss the plan for IPD opening.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Encephalitis
Inflammation
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases