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

Parkinson's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224263
• Other study ID #: 2004BA702B02
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: August 15, 2011
• Start date: September 2005
• Est. completion date: February 2008

Study information

• Verified date: August 2011
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Lingzhi (Ganoderma)

Locations

Country	Name	City	State
China	Xuanwu Hospital	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	Motor Function
Secondary	Cognition
Secondary	Mood
Secondary	Quality of Daily Life