Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
1 other identifier
interventional
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 parkinson-disease
Started Jul 2018
Typical duration for phase_3 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2018
CompletedStudy Start
First participant enrolled
July 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 26, 2021
August 1, 2021
3.5 years
July 11, 2018
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Changes in ADAS-COG scores
72 weeks
Study Arms (2)
Early-start Group
EXPERIMENTALReceiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks
Delayed-start Group
PLACEBO COMPARATORReceiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erhe Xu, M.D.
Xuanwu Hospital of Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2018
First Posted
July 20, 2018
Study Start
July 15, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08