Parkinson Disease
Conditions
Keywords
Parkinson's disease, Lingzhi, Traditional Chinese Medicine
Brief summary
Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients.
Interventions
DRUGGanoderma
0.8g twice daily
DRUGPlacebos
0.8g twice daily
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Meeting the criteria for Probable Parkinson's disease according to 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease * Aged 30-80 years * Hoehn-Yahr Stage≤2 * UPDRS Part III subscores ranging from 10 to 30 points * Disease duration of 5 years or less * Untreated with antiparkinsonian drugs for at least two weeks preceding the trial * Willing to sign the written informed consent
Exclusion criteria
* Atypical or secondary parkinsonism * With psychiatric symptoms or a history of psychiatric diseases * With cognitive impairment(MMSE score\<24) * Major liver or kidney dysfunction * Participating in other clinical trials within 3 months preceding the current trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in UPDRS Part III subscores | 72 weeks | Compare changes in UPDRS part III scores from baseline to week 72 between early-start group and delayed-start group |
| Changes in Schwab-England scores | 72 weeks | Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group |
| Ratios of subjects in need of additional antiparkinsonian drugs | 72 weeks | Compare ratios of subjects in need of additional antiparkinsonian drugs during the 72 week period between early-start group and delayed-start group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ADAS-COG scores | 72 weeks | Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group |
Countries
China
Contacts
Primary ContactErhe Xu, M.D.
Outcome results
None listed