The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease
Keywords
Abstract
Description
Inclusion criteria:
1. PD patients aged 50-79 years diagnosed by neurologist (should exclude vascular parkinsonism, secondary parkinsonism( including toxin, drug, heavy metal, CO intoxication), normal pressure hydrocephalus, multiple system atrophy, progressive supranuclear palsy, cortical basal degeneration, dementia with Lewy Body, hereditary parkinson's disease with genetic mutation, Huntington's disease, Wilson disease, spinal cerebellar ataxia with extrapyramidal syndrome, essential tremor, dystonia)
2. PD at Hoehn and Yahr stage 2-2.5
3. without cognitive decline
Exclusion criteria:
1. with diabetes mellitus (DM)
2. with nephropathy (GFR < 30ml/min)
3. with significant neurological deficits caused by vascular insults
Measurement parameters:
1. At recruitment: blood sugar, AST, ALT, BUN, Crea, Ca, Na, K and peripheral blood cell (for the expression levels of KATP)
2. every 6 months: motor symptoms: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
3. every 1 year: CASI, tilting table, AST, ALT, BUN, crea, Na, K, Ca
Protocol:
0 month (initial baseline):
1. blood sugar, AST, ALT, BUN, Crea, Ca, Na, K and peripheral blood cell
2. Tilting table test (autonomic function)
3. CASI cognitive test
4. UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
5. stool microbiota
6 months: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
12 months:
1. UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
2. CASI cognitive test, tilting table, AST, ALT, BUN, crea, Na, K, Ca
18 months: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
24 months:
1. UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
2. CASI cognitive test, tilting table, AST, ALT, BUN, crea, Na, K, Ca
3. stool microbiota
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 11/19/2019 |
| Estimated Enrollment Submitted: | 06/08/2020 |
| First Posted: | 06/10/2020 |
| Last Update Submitted: | 06/08/2020 |
| Last Update Posted: | 06/10/2020 |
| Actual Study Start Date: | 02/02/2020 |
| Estimated Primary Completion Date: | 03/19/2022 |
| Estimated Study Completion Date: | 03/19/2023 |
Condition or disease
Intervention/treatment
Dietary Supplement: Hericium erinaceus mycelium
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Hericium erinaceus mycelium Hericium erinaceus capsules 1 table tid orally per day for 24 months | |
| Placebo Comparator: placebo placebo capsules 1 table tid orally per day for 24 months |
Eligibility Criteria
| Ages Eligible for Study | 50 Years To 50 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. baseline [0 month]
2. 1st [6 momths]
3. 2nd [12 months]
4. 3rd [18 months]
5. final [24 months]
