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

NCT00224263 | Completed Phase 2 DMC

• 1 other identifier: 2004BA702B02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Keywords

Traditional Chinese Medicine; Lingzhi

Outcome Measures

Primary Outcomes (1)

• Motor Function

Secondary Outcomes (3)

• Cognition

• Mood

• Quality of Daily Life

Interventions

Lingzhi (Ganoderma) DRUG

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Piu Chan, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Study Completion: February 1, 2008
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

CN (1)