Parkinson DiseasePhase 3NCT03594656
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
A Phase 3 study testing Ganoderma in people with Parkinson Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ganoderma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2018to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Erhe Xu, M.D., 010-83198677, xuerhe@163.com
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Ganoderma, Placebos
- Keywords
- Parkinson's disease, Lingzhi, Traditional Chinese Medicine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanodermaDrug
Also called Lingzhi
0.8g twice daily
PlacebosDrug
0.8g twice daily
| Study group | Role | What they receive |
|---|---|---|
| Early-start Group | Experimental | Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks Receives: Drug: Ganoderma |
| Delayed-start Group | Placebo comparator | Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks Receives: Drug: Ganoderma; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 weeks
Changes in Schwab-England scores
Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group
Measured: 72 weeks
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
Measured: 72 weeks
Secondary outcomes (1)
Changes in ADAS-COG scores
Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start15 Jul 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erhe Xu, M.D., Principal investigator, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594656
- Sponsor's protocol ID
- 2017YFC1310202
- Status last verified
- Aug 2021
- First submitted
- 11 Jul 2018
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03594656
- Acronym / sponsor ID
- 2017YFC1310202
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Lingzhi, Traditional Chinese Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-start Group | Experimental | Drug: GanodermaReceiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks |
| Delayed-start Group | Placebo comparator | Drug: Ganoderma, Drug: PlacebosReceiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GanodermaAlso: Lingzhi0.8g twice daily | Drug | Delayed-start Group, Early-start Group |
| Placebos0.8g twice daily | Drug | Delayed-start Group |
Primary outcome
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
1 secondary outcome
Changes in ADAS-COG scores
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhe Xu, M.D. principal investigator
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ganoderma in people with Parkinson Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erhe Xu, M.D. (010-83198677, xuerhe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in UPDRS Part III subscores (time frame: 72 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.