Clinical study of Ganoderma lucidum extract in the treatment of motor and non motor symptoms in patients with early PD
- Conditions
- Parkinson's disease
- Registration Number
- ITMCTR2100005251
- Lead Sponsor
- Xuanwu Hospital of Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
A) Meets the diagnostic criteria of clinically probable PD for primary Parkinson's disease of MDS;
B) Age 30-80 at diagnosis of Parkinson's disease;
C) H-Y clinical grade =2;
D) UPDRS H2o between 10 and 30 points (10 and 30 points);
E) The course of disease does not exceed 5 years;
F) Is not receiving anti-Parkinson's drugs or other treatment, or has been discontinued for more than 2 weeks (including dopamine preparations, dopamine agonists, COMT inhibitors, MAO inhibitors, antan, amantadine);
G) Agree to participate in this study, sign the informed consent, abide by the relevant experimental regulations, take medication on time and come for regular review;
H) Agree to be treated only with experimental drugs for the next 1.5 years, and to take anti-Parkinson's drugs as prescribed if necessary.
A) Patients with atypical or secondary Parkinson's disease;
B) A history of psychiatric symptoms or mental illness;
C) Cognitive impairment (MDSE =24);
D) Participating in other drug trials within the past 3 months;
E) Severe liver and renal function abnormalities (more than 3 times the normal mean);
F) ongoing use of anti-Parkinson's drugs;
G) Not to sign the informed consent
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MDS-UPDRS;
- Secondary Outcome Measures
Name Time Method Parkinson's Syndrome Scale of Chinese medicine;ADAS-cog;Parkinson's sleep scale;Olfactory Argentine Questionnaire;Depression Scale GDS-30;ROME?;MMSE&MoCA;Parkinson's Pain assessment Scale;Schwab-England Disability Scale;