Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT03594656 |
Recruitment Status :
Recruiting
First Posted : July 20, 2018
Last Update Posted : August 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Ganoderma Drug: Placebos | Phase 3 |
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 : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

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 |
- 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
- 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

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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 |
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

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
Contact: Erhe Xu, M.D. | 010-83198677 | xuerhe@163.com |
China, Beijing | |
Xuanwu Hospital of Capital Medical University | Recruiting |
Beijing, Beijing, China, 100053 | |
Contact: Erhe Xu, M.D. 010-83198677 xuerhe@163.com |
Principal Investigator: | Erhe Xu, M.D. | Xuanwu Hospital of Capital Medical University |
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: | August 26, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson's disease Lingzhi Traditional Chinese Medicine |
Parkinson Disease Disease Progression Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Disease Attributes Pathologic Processes |