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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lingzhi (Ganoderma)
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Traditional Chinese Medicine, Lingzhi

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xuanwu Hospital

Outcomes

Primary Outcome Measures

Motor Function

Secondary Outcome Measures

Cognition
Mood
Quality of Daily Life

Full Information

First Posted
September 20, 2005
Last Updated
August 15, 2011
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT00224263
Brief Title
Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Traditional Chinese Medicine, Lingzhi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lingzhi (Ganoderma)
Primary Outcome Measure Information:
Title
Motor Function
Secondary Outcome Measure Information:
Title
Cognition
Title
Mood
Title
Quality of Daily Life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piu Chan, MD, PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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