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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04428983
Date of registration: 20/11/2019
Prospective Registration: Yes
Primary sponsor: National Cheng-Kung University Hospital
Public title: The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease
Scientific title: The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease
Date of first enrolment: February 3, 2020
Target sample size: 80
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04428983
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Yuan-Ting Sun, MD PhD
Address: 
Telephone: +886-6-2353535
Email: ytsun@mail.ncku.edu.tw
Affiliation: 
Name:     Li-Ya Lee
Address: 
Telephone:
Email:
Affiliation:  Bioengineering Center, Grape King Bio
Name:     Li-Ya Lee
Address: 
Telephone: +886-3-4572525
Email: ly.lee@grapeking.com.tw
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- idiopathic PD patients, aged 50-79 years

- modified Hoehn & Yahr stage 2-2.5

- Without subjective and objective cognitive decline (objective cognitive decline will
be determined by CASI)

Exclusion Criteria:

- With diabetes

- With end stage renal disease under hemodialysis

- With significant vascular insults that resulted in significant neurological deficits



Age minimum: 50 Years
Age maximum: 79 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Dietary Supplement: Hericium erinaceus mycelium
Primary Outcome(s)
2nd [Time Frame: 12 months]
baseline [Time Frame: 0 month]
final [Time Frame: 24 months]
3rd [Time Frame: 18 months]
1st [Time Frame: 6 momths]
Secondary Outcome(s)
Secondary ID(s)
HELPD V4 20191120
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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