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

Phase 3

• Conditions: Parkinson Disease
• Interventions: Drug: Ganoderma; Drug: Placebos

• Registration Number: NCT03594656
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study Start: 2018-07-15
• Study First Posted: 2018-07-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early-start Group	Ganoderma	Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks
Delayed-start Group	Ganoderma	Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
Delayed-start Group	Placebos	Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks

Primary Outcome Measures

Name	Time	Method
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
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
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China