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

NCT ID: NCT03594656

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Early-start Group

Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks

Group Type EXPERIMENTAL

Ganoderma

Intervention Type DRUG

0.8g twice daily

Delayed-start Group

Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks

Group Type PLACEBO_COMPARATOR

Ganoderma

Intervention Type DRUG

0.8g twice daily

Placebos

Intervention Type DRUG

0.8g twice daily

Interventions

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Ganoderma

0.8g twice daily

Intervention Type DRUG

Placebos

0.8g twice daily

Intervention Type DRUG

Other Intervention Names

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Lingzhi

Eligibility 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erhe Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital of Capital Medical University

Locations

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Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Erhe Xu, M.D.

Role: CONTACT

010-83198677

Facility Contacts

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Erhe Xu, M.D.

Role: primary

010-83198677

Other Identifiers

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2017YFC1310202

Identifier Type: -

Identifier Source: org_study_id

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