Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-start Group | Experimental | Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks |
|
| Delayed-start Group | Placebo Comparator | Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganoderma | Drug | 0.8g twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in UPDRS Part III subscores | Compare changes in UPDRS part III scores from baseline to week 72 between early-start group and delayed-start group | 72 weeks |
| Changes in Schwab-England scores | Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group | 72 weeks |
| Ratios of subjects in need of additional antiparkinsonian drugs | Compare ratios of subjects in need of additional antiparkinsonian drugs during the 72 week period between early-start group and delayed-start group | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ADAS-COG scores | Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group | 72 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erhe Xu, M.D. | Contact | 010-83198677 | xuerhe@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Erhe Xu, M.D. | Xuanwu Hospital of Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital of Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebos | Drug | 0.8g twice daily |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |