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Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Primary Purpose

Inflammation, Brain, Emotional Problem

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
beverage containing mushroom-extracts
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation, Brain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active arm

Placebo arm

Arm Description

Subjects will receive treatment with active beverage containing the active ingredient

Subjects will receive treatment with placebo beverage not containing the active ingredient

Outcomes

Primary Outcome Measures

Change of subjective depressive symptoms
Measured by Beck Depression Inventory-II
Change of objective depressive symptoms
Measured by Hamilton Rating Scale for Depression
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.
Cortisol level
Measured as a stress-related biomarker

Secondary Outcome Measures

Full Information

First Posted
June 20, 2019
Last Updated
October 7, 2022
Sponsor
National Science Council, Taiwan
Collaborators
National Taiwan University
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1. Study Identification

Unique Protocol Identification Number
NCT04002219
Brief Title
Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Official Title
Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Science Council, Taiwan
Collaborators
National Taiwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Brain, Emotional Problem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A triple-blind, randomized-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Experimental
Arm Description
Subjects will receive treatment with active beverage containing the active ingredient
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Subjects will receive treatment with placebo beverage not containing the active ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
beverage containing mushroom-extracts
Intervention Description
Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.
Primary Outcome Measure Information:
Title
Change of subjective depressive symptoms
Description
Measured by Beck Depression Inventory-II
Time Frame
8 weeks
Title
Change of objective depressive symptoms
Description
Measured by Hamilton Rating Scale for Depression
Time Frame
8 weeks
Title
Change of somatic symptoms
Description
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.
Time Frame
8 weeks
Title
Cortisol level
Description
Measured as a stress-related biomarker
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuan-Pin Su, MD, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study has not yet fully discuss the plan for IPD opening.

Learn more about this trial

Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

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