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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ganoderma
Placebos
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Lingzhi, Traditional Chinese Medicine

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xuanwu Hospital of Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Early-start Group

Delayed-start Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in UPDRS Part III subscores
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
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
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

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

Full Information

First Posted
July 11, 2018
Last Updated
August 24, 2021
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT03594656
Brief Title
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
Official Title
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Lingzhi, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early-start Group
Arm Type
Experimental
Arm Description
Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks
Arm Title
Delayed-start Group
Arm Type
Placebo Comparator
Arm Description
Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ganoderma
Other Intervention Name(s)
Lingzhi
Intervention Description
0.8g twice daily
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
0.8g twice daily
Primary Outcome Measure Information:
Title
Changes in UPDRS Part III subscores
Description
Compare changes in UPDRS part III scores from baseline to week 72 between early-start group and delayed-start group
Time Frame
72 weeks
Title
Changes in Schwab-England scores
Description
Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group
Time Frame
72 weeks
Title
Ratios of subjects in need of additional antiparkinsonian drugs
Description
Compare ratios of subjects in need of additional antiparkinsonian drugs during the 72 week period between early-start group and delayed-start group
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Changes in ADAS-COG scores
Description
Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erhe Xu, M.D.
Phone
010-83198677
Email
xuerhe@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erhe Xu, M.D.
Organizational Affiliation
Xuanwu Hospital of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erhe Xu, M.D.
Phone
010-83198677
Email
xuerhe@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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