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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used traditional Chinese Medicine is effective and safe in the treatment of Parkinson's disease when combined use with L-dopa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanwu Hospital, Beijing

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