Parkinson's disease
Conditions
Interventions
Experimental Group A:PD basic treatment combined with human intestinal active microbiota capsules
Experimental Group B:PD basic treatment combined with Shudipingchan granule
Control group A:PD basic treatment combined with microbiota placebo capsules
Control group B:PD basic treatment combined with Shudipingchan granule 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: 1) Age range of 30-80 years old, gender not limited; 2) Meets the diagnostic criteria for primary Parkinson's disease revised by The Movement Disorder Society (MDS) in 2015; 3) Hoehn Yahr stage = 3 stages; 4) For subjects who have already undergone anti Parkinson's treatment (levodopa preparations, dopamine receptor agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase inhibitors, anticholinergic drugs, etc.), it is required that the dosage of anti Parkinson's drugs be relatively stable for at least 3 months before this clinical trial, and there are no clear plans to change the existing treatment regimen in the next 3 months; 5) Voluntarily participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with Parkinson's disease syndrome or Parkinson's disease combined syndrome; 2) Active depression or psychosis and/or antidepressant or antipsychotic medication treatment; 3) Severe post-stroke sequelae and other systemic diseases such as heart, lung, liver, kidney, etc; 4) History of drug abuse or alcoholism; 5) The contraindications for severe gut microbiota transplantation include gastrointestinal bleeding, severe damage to the intestinal mucosa, and severe immune dysfunction in the population; 6) Pregnant or lactating women; 7) Patients who are currently participating in other clinical studies or have participated in other clinical studies within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale, UPDRS;PDQ-39;GSRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hoehn Yahr grading;SCOPA-AUT;Peripheral blood cytokines;Intestinal microbiota testing;Intestinal metabolites testing; | — |
Countries
China
Contacts
Public ContactYe Qing
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed