Parkinson's disease
Conditions
Interventions
Traditional Chinese Medicine Treatment group:Tianqi pingchan Granule
Sponsors
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Patients aged 40–75 years who meet the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria for Parkinsons disease (PD); 2) Presence of wearing-off phenomenon indicated by a Wearing-Off Questionnaire-9 (WOQ-9) score = 3; 3) Stable anti-PD treatment regimen for at least 30 days prior to enrollment with levodopa administered at least 3 times daily and a total daily dose = 300 mg; 4) Patients with either of the following Traditional Chinese Medicine (TCM) syndrome types: - Qi and Blood Deficiency Syndrome** (manifested as mental sluggishness reluctance to speak pale complexion prolonged limb tremor or head shaking severe tremor neck/back rigidity or limb stiffness reduced mobility unsteady gait shortness of breath fatigue dizziness blurred vision spontaneous sweating exacerbated by activity seborrhea or drooling enlarged tongue with tooth marks pale-dark tongue thin white or white greasy coating weak or deep-thin pulse); - Liver and Kidney Deficiency Syndrome** (manifested as expressionless face prolonged limb tremor or head shaking large-amplitude tremor limb stiffness clumsy movement impaired upper limb coordination shuffling gait slurred speech cognitive decline emaciation dizziness tinnitus insomnia dream-disturbed sleep headache night sweats worsening tremor during agitation soreness and weakness of the waist and legs frequent urination constipation small and dark-red tongue scanty or peeled or slightly yellow coating thin-wiry or thin-rapid pulse); 5) Agreement not to adjust anti-PD treatment during the trial; 6) Willingness to participate in the trial with signed informed consent provided by the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: 1) Non-idiopathic PD patients or those with severe organic diseases (e.g. heart disease hypertension tuberculosis nephritis etc.); 2) PD patients who have undergone relevant surgical treatments (including pallidotomy thalamotomy or deep brain stimulation); 3) Pregnant or lactating women; 4) Patients who have taken other traditional Chinese medicine (TCM) prescriptions or Chinese patent medicines for Parkinsons disease within 2 weeks prior to enrollment; or those currently participating in other clinical trials or who have participated in other clinical studies within 30 days before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of WOQ-19 score compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of the PD Non-Motor Symptom Fluctuation Scale (NoMoFu Scale) compared with the baseline;The changes of the PD Quality of Life Scale (PDQ-39) compared with the baseline;The proportion of patients with an additional dose of L-dopa during the treatment period;The changes of MDS-UPDRS III and IV- scores compared with the baseline; | — |
Countries
China
Contacts
Public ContactLiu Zhenguo
Shanghai Jiao Tong University School of Medicine
Outcome results
None listed