Parkinson's disease
Conditions
Interventions
Group A:Administer omeprazole enteric coated capsules 20mg, 1 #, twice daily
After the washout period, give excipient capsules that do not contain the above drug ingredients, 1 #, twice a day
Group B:Administer excipient capsules that do not contain the above medicinal ingredients, 1 #, twice a day
After the washout period, administer omeprazole enteric coated capsules 20mg, 1 #, twice a day
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age range from 40 to 85 years old, regardless of gender; 2) Patients with primary Parkinson's disease meet the clinical diagnostic criteria for Parkinson's disease MDS (2016); 3) The score for item 2.6 in the second part of UPDRS is 1-4 points; 4) The motor and salivation symptoms of Parkinson's disease were stable in the first month before enrollment, and there was no adjustment in medication for all Parkinson's diseases in the first month before enrollment; Two weeks prior to enrollment, no anticholinergic drugs such as bromobistigmine, dihydroergot mesylate, or atropine were taken, and no drugs such as botulinum toxin were injected. 5) No PPI, antibiotics, probiotics or prebiotics were used for the first 2 months before enrollment. If used, a 2-month washout period should be carried out; 6) Understand and agree to comply with the research protocol, agree to be enrolled, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Parkinson's superimposition syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, Louis body dementia, vascular Parkinson's syndrome, post encephalitis Parkinson's syndrome, or any other non primary Parkinson's disease; 2) Long term smoking history before enrollment; 3) The medication for Parkinson's disease was adjusted one month before enrollment; Taking anticholinergic drugs such as atropine and injecting botulinum toxin within one month before enrollment; 4) A history of salivary related diseases that may affect salivary secretion function, including but not limited to the following diseases: primary or secondary Sjögren syndrome and sarcoidosis, or organ dysfunction, such as salivary stones; 5) Severe cardiovascular diseases (such as congestive heart failure classified as Grade III-IV by the American Heart Association, history of myocardial infarction within 6 months, etc.); 6) Severe liver and kidney dysfunction; 7) Pregnant and lactating women or pregnant women aged 40-60 who are HCG positive; 8) Individuals who are known to be allergic to omeprazole enteric coated capsules or their excipients; 9) Individuals with a history of drug abuse or alcohol dependence; 10) Individuals who were participating in other clinical trials at the time of enrollment; 11) Refusal to join and inability to cooperate with researchers; The researchers determined that patients were not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in response rates between two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average UPDRS2.6 score;SCS-PD score average;Average UPDRS III motor symptom score;Average DSFS score;Cleveland Constipation Score;Gastrointestinal Symptom Assessment Scale Score;CGI-I CGI-S Score;Average saliva flow rate;Salivary inflammatory factor detection;Salivary and gut microbiota abundance detection;Self expression of H+- K+- ATPase and H2 receptor in salivary gland (labial gland) tissue; | — |
Countries
China
Contacts
Public ContactHouzhen Tuo
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed