Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00224263
• Date of registration: 20/09/2005
• Prospective Registration: No
• Primary sponsor: Xuanwu Hospital, Beijing
• Public title: Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI
• Date of first enrolment: September 2005
• Target sample size: 360
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00224263
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Piu Chan, MD, PhD
• Affiliation: Xuanwu Hospital, Beijing

Key inclusion & exclusion criteria

Inclusion Criteria:

- willing and able to give informed consent

- age 30 years or older at time of diagnosis of Parkinson's disease

- have idiopathic Parkinson's disease, defined as:

- having at least 2 of the following 4 signs: resting tremor, bradykinesia,
rigidity, or postural reflex impairment, at least one of which must be resting
tremor or bradykinesia

- no secondary or atypical parkinsonism

- asymmetric features (current signs or history of asymmetric onset)

- response to L-dopa, by patient self-report

- Parkinson's disease duration of no more than 5 years

- receiving stable therapy of L-dopa/DCI for at least 3 months; acceptable dose range:
250 mg - 1000 mg L-dopa/DCI daily

- Hoehn and Yahr stage < 4 on stable L-dopa/DCI treatment

Exclusion Criteria:

- have atypical parkinsonism due to drugs, metabolic disorders, encephalitis, or other
neurodegenerative diseases

- have any other known medical or psychiatric condition that may compromise their
participation in the study

- have taken another investigational drug within 90 days of baseline

- have a change in dosage of any other antiparkinsonian drug (eg, pramipexole,
ropinirole, pergolide, bromocriptine, methylphenidate, anticholinergics, or
amantadine) during the study or within 90 days prior to baseline

- have received treatment with dopamine blocking agents (including neuroleptic agents,
antiemetic agents), dopamine-depleting agents (including reserpine or tetrabenazine)
within 90 days prior to baseline

- do not consent to participate



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Lingzhi (Ganoderma)

Primary Outcome(s)

Motor Function

Secondary Outcome(s)

Cognition

Mood

Quality of Daily Life

Secondary ID(s)

2004BA702B02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors