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
- 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
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.
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
Name Time Method Time of first addition of Levodopa;Duration of OFF period;The Parkinson's Disease Questionnaire(PDQ-39);
- Secondary Outcome Measures
Name Time Method