Parkinson's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meets the diagnostic criteria of the United Kingdom(UK) Parkinson's Disease(PD)Brain Bank and is in Hoehn-Yahr (H&Y) stages 1 to 3; 2) Primary PD patients aged 40 to 85 years old, regardless of gender; 3) Normal cognitive function assessed by the Mini-Mental State Examination (MMSE) scale (MMSE score >23 points. Illiterate (uneducated) >17 points, primary school (6 years of education) >20 points, secondary school and above (more than 6 years of education) >23); 4) Receiving sedatives, hypnotics, and conventional anti-PD Western medicine treatment, with stable dosage for at least 28 days prior to consultation; 5) Voluntarily participates, understands, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with atypical Parkinson's syndrome or cancer; 2) Individuals with alcohol or illicit drug abuse; 3) Patients with a history of delirium, epilepsy, severe illnesses, or other circumstances where participation is not suitable; 4) Patients with significantly abnormal liver or kidney function in laboratory tests (those with Child-pugh score B or C grade, or Meld score >18 points are considered to have significantly abnormal liver function; those meeting the criteria for acute kidney injury, acute kidney disease, or chronic kidney disease according to the KDIGO guidelines are considered to have significantly abnormal kidney function).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale (ESS);Parkinson's Disease Sleep Scale (PDSS);Depression Symptoms Self-Rating Scale(BDI-II);Self-Rating Anxiety Scale (SAS);Polysomnography (PSG) Data;Evaluation of Restless Legs Syndrome;Orthostatic hypotension changes;Dyskinesia UDysRS Rating(UDysRS);Pain Numerical Rating Scale (NRS) Score;Gastrointestinal Symptom Rating Scale(GSRS);Parkinson's Disease Questionnaire-39 (PDQ-39) ;Traditional Chinese Medicine (TCM) Syndrome Scale;Levodopa equivalent daily dose(LEDD) Dosage Variation;Neurotransmitters in peripheral blood;Changes in gut microbiota;Salivary a-syn and associated inflammatory markers;Functional Magnetic Resonance Imaging (fMRI);Routine Liver Function Tests;Routine Renal Function Tests; | — |
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale-III(UPDRS-III) Motor Examination 14-Item; | — |
Countries
China
Contacts
Second Affiliated Hospital of Zhejiang Chinese Medical University