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

August 24, 2021 updated by: Xuanwu Hospital, Beijing

Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Erhe Xu, M.D.
  • Phone Number: 010-83198677
  • Email: xuerhe@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital of Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 weeks
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
72 weeks
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
72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017YFC1310202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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