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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Recruiting
CT.gov ID
NCT03594656
Collaborator
(none)
288
Enrollment
1
Location
2
Arms
41.6
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 15, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • Lingzhi

    • Drug: Placebos
    0.8g twice daily

    Outcome Measures

    Primary Outcome Measures

    1. Changes in UPDRS Part III subscores [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 [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 [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 [72 weeks]

      Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Stageā‰¤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

    Locations

    Site City State Country Postal Code
    1 Xuanwu Hospital of Capital Medical University Beijing Beijing China 100053

    Sponsors and Collaborators

    • Xuanwu Hospital, Beijing

    Investigators

    • Principal Investigator: Erhe Xu, M.D., Xuanwu Hospital of Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xuanwu Hospital, Beijing
    ClinicalTrials.gov Identifier:
    NCT03594656
    Other Study ID Numbers:
    • 2017YFC1310202
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    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:
    Parkinson Disease
    Disease Progression

    Study Results

    No Results Posted as of Aug 26, 2021