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

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ClinicalTrials.gov Identifier: NCT03594656
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

July 11, 2018
July 20, 2018
July 20, 2018
July 15, 2018
June 30, 2019   (Final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
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 do novo PD patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Ganoderma
    0.8g twice daily
    Other Name: Lingzhi
  • Drug: Placebos
    0.8g twice daily
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
288
Same as current
December 31, 2020
June 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Older Adult)
No
Contact: Erhe Xu, M.D. 010-83198677 xuerhe@163.com
Not Provided
 
 
NCT03594656
2017YFC1310202
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Xuanwu Hospital, Beijing
Xuanwu Hospital, Beijing
Not Provided
Principal Investigator: Erhe Xu, M.D. Xuanwu Hospital of Capital Medical University
Xuanwu Hospital, Beijing
July 2018

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