Parkinson's Disease
Conditions
Interventions
Control Group of Moderate PD:Placebo
Intervention Group of advanced PD:Fuzheng Pingchan Decoction
Control Group of mild PD:placebo
Intervention Group of mild PD:Ziyin Pingchan Decoction
Intervention Group of moderate PD:Jiedu Pingchan Decoction
Control Group of advanced PD:Placebo
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of first addition of Levodopa;Duration of "OFF" period;The Parkinson's Disease Questionnaire(PDQ-39); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale(HAMD);Hamilton Anxiety Scale(HAMA);Unified Dyskinesia Rating Scale(UDysRS);Parkinson's disease Sleep Scale-2(PDSS-2);REM sleep behavior disorder questionnaire(RBDSQ);Alanine aminotransferase(ALT);elderly quiver of TCM syndrome classification dysfunction score;uric acid(UA);White Blood Cell Count(WBC);serum creatinine(Scr);mini-mental state examination(MMSE);homocysteine(Hcy);Electrocardiogram(ECG);Unified Parkinson's disease Rating Scale(UPDRS);Aspartate aminotransferase(AST);bed rest;Red Blood Cell Count(RBC);Freezing of Gait Questionnaire(FOGQ);the Epworth Sleeping Scale(ESS);Caregivers Burden Inventory(CBI);scales for Outcomes in Parkinson's disease – Autonomic(SCOPA-AUT);Alanine aminotransferase(ALT);Webster Clinical Symptom Scale;Hoehn Yahr stage;non-motor symptom scale(NMSS);survival;Platelet Count(PLT);Wearing-off-9 Questionnaire (WOQ-9);The Parkinson's Disease Questionnaire(PDQ-39);infection;abnormal involuntary movement scale(AIMS);hospitalization;Parkinson disease dyskinesia scale(PDYS-26); | — |
Countries
China
Contacts
Public ContactCanxing Yuan
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Outcome results
None listed