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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594656
• Other study ID #: 2017YFC1310202
• Status: Recruiting
• Phase: Phase 3
• Start date: July 15, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Xuanwu Hospital, Beijing
• Contact: Erhe Xu, M.D.
• Phone: 010-83198677
• Email: xuerhe[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Parkinson Disease

Intervention

Drug:
• Ganoderma
0.8g twice daily
• Placebos
0.8g twice daily

Locations

Country	Name	City	State
China	Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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