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Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594656
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Study Description
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Brief Summary:
Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Ganoderma Drug: Placebos Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Early-start Group
Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks
 Drug: Ganoderma
0.8g twice daily
Other Name: Lingzhi
Placebo Comparator: Delayed-start Group
Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
 Drug: Ganoderma
0.8g twice daily
Other Name: Lingzhi

Drug: Placebos
0.8g twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Changes in UPDRS Part III subscores [ Time Frame: 72 weeks ]
    Compare changes in UPDRS part III scores from baseline to week 72 between early-start group and delayed-start group

  2. Changes in Schwab-England scores [ Time Frame: 72 weeks ]
    Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group

  3. Ratios of subjects in need of additional antiparkinsonian drugs [ Time Frame: 72 weeks ]
    Compare ratios of subjects in need of additional antiparkinsonian drugs during the 72 week period between early-start group and delayed-start group


Secondary Outcome Measures :
  1. Changes in ADAS-COG scores [ Time Frame: 72 weeks ]
    Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meeting the criteria for "Probable Parkinson's disease" according to 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease
  • Aged 30-80 years
  • Hoehn-Yahr Stage≤2
  • UPDRS Part III subscores ranging from 10 to 30 points
  • Disease duration of 5 years or less
  • Untreated with antiparkinsonian drugs for at least two weeks preceding the trial
  • Willing to sign the written informed consent

Exclusion Criteria:

  • Atypical or secondary parkinsonism
  • With psychiatric symptoms or a history of psychiatric diseases
  • With cognitive impairment(MMSE score<24)
  • Major liver or kidney dysfunction
  • Participating in other clinical trials within 3 months preceding the current trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594656


Contacts
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Contact: Erhe Xu, M.D. 010-83198677 xuerhe@163.com

Locations
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China, Beijing
Xuanwu Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Erhe Xu, M.D.    010-83198677    xuerhe@163.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Erhe Xu, M.D. Xuanwu Hospital of Capital Medical University
More Information
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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03594656    
Other Study ID Numbers: 2017YFC1310202
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuanwu Hospital, Beijing:
Parkinson's disease
Lingzhi
Traditional Chinese Medicine
Additional relevant MeSH terms:
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Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes