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

This study has been completed.
Sponsor:
Information provided by:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT00224263
First received: September 20, 2005
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Lingzhi (Ganoderma)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Xuanwu Hospital, Beijing:

Primary Outcome Measures:
  • Motor Function

Secondary Outcome Measures:
  • Cognition
  • Mood
  • Quality of Daily Life

Estimated Enrollment: 360
Study Start Date: September 2005
Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224263

Locations
China
Xuanwu Hospital
Beijing, China
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Principal Investigator: Piu Chan, MD, PhD Xuanwu Hospital, Beijing
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00224263     History of Changes
Other Study ID Numbers: 2004BA702B02
Study First Received: September 20, 2005
Last Updated: August 15, 2011
Health Authority: China: Ministry of Health

Keywords provided by Xuanwu Hospital, Beijing:
Traditional Chinese Medicine
Lingzhi

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 27, 2014