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Clinical Study on Evidence-Based Evaluation of Syndrome Differentiation and Treatment by Stages of Parkinson's Disease in Cheng Menxue's Academic Experience Inherited from DING's Internal Medicine

Not Applicable
Conditions
Parkinson's Disease
Registration Number
ITMCTR2200005603
Lead Sponsor
onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

For mild PD:
1. Meet the Idiopathic Parkinson's disease diagnostic criteria revised by The Movement Disorder Society (MDS) in 2015;
2.Hoehn Yahr stage =2;
3. Age between 30 and 80, regardless of gender;
4. Patients who have or have not been treated with anti-Parkinson drugs can be included. For participants who are receiving anti-Parkinson treatment (levodopa preparations, dopamine agonists, monoamine oxidase inhibitors, Catechins - O - Methyl Transferase (COMT) inhibitor, anticholinergic drugs, etc.), the dosage of anti-Parkinson drug is requested to be relatively stable for at least 3 months before this clinical trial, and no plan has been made to change existing treatment in the next 3 months.
5. Voluntarily participate and sign informed consent.
For moderate PD
1. Meet the diagnostic criteria of Idiopathic Parkinson's disease revised by MDS in 2015.
2. Hoehn Yahr stage 2.5 or 3;
3. 30-80 years old, no gender limitation, accompanied by wearing-off phenomenon, and/or the following motor complications: peak dyskinesia, biphasic dyskinesia, dysmyotonia, on-off phenomenon;
4. Dosage of anti-Parkinson drug (levodopa preparations, dopamine agonists, monoamine oxidase inhibitors, Catechins - O - Methyl Transferase (COMT) inhibitor, anticholinergic drugs, etc.) is requested to be relatively stable for at least 3 months before this clinical trial, and no plan has been made to change existing treatment in the next 3 months.
5. Voluntarily participate and sign informed consent.
For advanced patients
1. The diagnostic criteria of Idiopathic Parkinson's disease revised by MDS in 2015 were met;
2. Hoehn Yahr stage =4;
3. Age between 30 and 80, regardless of gender;
4. Dosage of anti-Parkinson drug (levodopa preparations, dopamine agonists, monoamine oxidase inhibitors, Catechins - O - Methyl Transferase (COMT) inhibitor, anticholinergic drugs, etc.) is requested to be relatively stable for at least 3 months before this clinical trial, and no plan has been made to change existing treatment in the next 3 months.
5. Voluntarily participate and sign informed consent.

Exclusion Criteria

For mild PD:
1. Patients with Parkinson Syndrome (PS) or Parkinsonism-Plus syndrome (PPS);
2. Active depression or psychosis and/or under antidepressant or antipsychotic medication;
3. Severe sequelae of stroke and other systemic diseases such as heart, lung, liver and kidney;
4. History of drug or alcohol abuse;
5. Being participating in other clinical studies or have participated in other clinical study within the previous 30 days.
For moderate PD
1. Patients with PS or PPS;
2. Pregnant or lactating women, history of drug or alcohol abuse;
3. Severe Cognitive impairment (Montreal Cognitive Assessment scale (MoCA)<20points), active depression or psychosis and/or under antidepressant or antipsychotic medication, severe sequelae of stroke and other systemic diseases such as heart, lung, liver and kidney;
5. Being participating in other clinical studies or have participated in other clinical study within the previous 30 days.
For advanced PD
1. Patients with PS or PPS;
2. Pregnant or lactating women, history of drug abuse or alcohol abuse;
3. Severe cognitive impairment (MoCA< 20 points), active depression or psychosis and/or under antidepressant or antipsychotic medication, severe sequelae of severe stroke and other systemic diseases such as heart, lung, liver and kidney;
5. Being participating in other clinical studies or have participated in other clinical study within the previous 30 days.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time of first addition of Levodopa;Duration of OFF period;The Parkinson's Disease Questionnaire(PDQ-39);
Secondary Outcome Measures
NameTimeMethod
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