parkinson’s disease
Conditions
Interventions
Low dose group:Promethazine oral 50mg/day
High dose group:Promethazine oral 100mg/day
Placebo group:Oral placebo
Sponsors
The first hospital of Yichang
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Patients who meet the diagnostic criteria of the British Parkinson's Disease Association Brain Bank and have a confirmed diagnosis of PD.2) Age = 40 years old.3) Those who have signed an informed consent form and are able to comply with the relevant study requirements.4) Ability to comply with scheduled return visits, medication schedules and laboratory related tests.5) The ability to receive oral medication in tablet form.6) The participant can accept that the original dosing regimen should be guaranteed from 4 weeks prior to the start of drug therapy to the end of the study. The regimen should be stable and unchanged from the end of the study.
Exclusion criteria
Exclusion criteria: 1) Participation in another interventional clinical trial or exposure to another trial drug within the first 6 months of participation in the trial drug, except for observational cohort studies or non-interventional studies.2) In the judgment of the investigator, the participant had a significant laboratory at the time of screening that could affect the safety indicators of abnormal laboratory tests.3) Participants with a medical history or current medical condition that, in the judgment of the investigator, may affect safety, including but not limited to: patients with creatinine clearance <50 ml/min, porphyria and allergy to phenobarbital, mental illness or brain dysfunction, respiratory conditions such as asthma or other conditions that may exacerbate respiratory distress or airway compromise, or cardiac disease.4) The participant has received treatment that includes a prescription/non-prescription drug that is a known cytochrome P3A4 (CYP3A4) enzyme inhibitor or inducer 14 days prior to the first dose.5) having coagulation disorders.6) Hepatic and renal insufficiency, proteinuria ++ and above.7) The degree of patient progression requires dopaminergic medication within the next 3 months or is expected to require dopaminergic drug therapy.8) Other serious illnesses, including mental illness.9) Subjects with a history of major surgery within 12 weeks prior to the start of study treatment or planned during the study Subjects with a history of major surgery (e.g., history of brain surgery) within 12 weeks prior to the start of study treatment or planned to have major surgery during the study period. 10) Hoehn & Yahr scores of 3 or higher at screening and UPDRS tremor scores of 3 or higher or above.11) Patients with cognitive impairment including impaired consciousness, severe aphasia, blindness, and deafness The patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RIPK1;RIPK3;MLKL;UPDRS;SCHWEB;England;Webster;IL-6;IL-1ß;IL-8;TNF-a; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAE/AE; | — |
Countries
China
Contacts
Public ContactYunhong Zha
The first hospital of Yichang
Outcome results
None listed