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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT03594656 |
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Date of registration:
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11/07/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
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Scientific title:
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Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial |
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Date of first enrolment:
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July 15, 2018 |
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Target sample size:
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288 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03594656 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Erhe Xu, M.D. |
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Address:
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Telephone:
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010-83198677 |
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Email:
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xuerhe@163.com |
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Affiliation:
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Name:
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Erhe Xu, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Xuanwu Hospital of Capital Medical University |
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Name:
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Erhe Xu, M.D. |
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Address:
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Telephone:
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010-83198677 |
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Email:
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xuerhe@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Placebos
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Drug: Ganoderma
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Primary Outcome(s)
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Changes in Schwab-England scores
[Time Frame: 72 weeks]
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Ratios of subjects in need of additional antiparkinsonian drugs
[Time Frame: 72 weeks]
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Changes in UPDRS Part III subscores
[Time Frame: 72 weeks]
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Secondary Outcome(s)
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Changes in ADAS-COG scores
[Time Frame: 72 weeks]
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Secondary ID(s)
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2017YFC1310202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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