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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Ganoderma
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early-start Group<br>Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks | Drug: Ganoderma<br>* 0.8g twice daily<br>* Other names: Lingzhi;|
| Placebo Comparator: Delayed-start Group<br>Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks | Drug: Ganoderma<br>* 0.8g twice daily<br>* Other names: Lingzhi;Drug: Placebos<br>* 0.8g twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Lingzhi, Traditional Chinese Medicine