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

Capital Medical University

Status and phase

Completed

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: Lingzhi (Ganoderma)

Study type

Interventional

Funder types

Other

Identifiers

NCT00224263

2004BA702B02

Details and patient eligibility

About

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.

Full description

This study is to focus on the effects of Lingzhi on non-motor symptoms of Parkinson's diseases as the primary outcome and on delaying the disease progression using the delay start design as the secondary outcome measurement. Two dosage groups and one placebo control group with total 360 subjects will be recruited. The treatment is one year.

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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