Overview

Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease

Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xuanwu Hospital, Beijing
Criteria
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 Stageā‰¤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