Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE July 15, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
Official Title  ICMJE Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Ganoderma
    0.8g twice daily
    Other Name: Lingzhi
  • Drug: Placebos
    0.8g twice daily
Study Arms  ICMJE
  • Experimental: Early-start Group
    Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks
    Intervention: Drug: Ganoderma
  • Placebo Comparator: Delayed-start Group
    Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
    Interventions:
    • Drug: Ganoderma
    • Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
288
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erhe Xu, M.D. 010-83198677 xuerhe@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594656
Other Study ID Numbers  ICMJE 2017YFC1310202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xuanwu Hospital, Beijing
Study Sponsor  ICMJE Xuanwu Hospital, Beijing
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erhe Xu, M.D. Xuanwu Hospital of Capital Medical University
PRS Account Xuanwu Hospital, Beijing
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP