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

August 15, 2011 updated by: Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

360

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Xuanwu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Motor Function

Secondary Outcome Measures

Outcome Measure
Cognition
Mood
Quality of Daily Life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Piu Chan, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004BA702B02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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