None listed
Conditions
Interventions
Control group:Basic treatment
Observation Group:Basic Treatment and Fengyin Decoction 200ml bid
Sponsors
Jiangsu Province Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years, no gender restrictions; 2. Meets clinical diagnostic criteria for Parkinson's disease; 3. Hoehn and Yahr stage 1–3; 4. Meets Traditional Chinese Medicine diagnostic criteria for tremor syndrome, with pattern differentiation as heat-excess wind-movement syndrome; 5. Voluntary participation with signed written informed consent, good compliance, willingness to attend follow-up appointments, and ability to self-attend hospital visits. The informed consent process must comply with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Parkinson's syndrome, such as that caused by medication, trauma or infection, or Parkinson's-overlapping syndromes such as multiple system atrophy, progressive supranuclear palsy and corticobasal degeneration; 2. Patients with severe cardiac, pulmonary, hepatic or renal impairment (e.g. transaminases > 1.5 times the upper limit of normal, or serum creatinine exceeding the upper limit of normal); 3. Pregnant or breastfeeding women; 4. Severe cognitive impairment affecting the description of symptoms and the assessment of subjective function; 5. Patients currently participating in other drug clinical trials within the past month; 6. Other conditions, as judged by the investigator, that may reduce the likelihood of enrolment or complicate the enrolment process, such as frequent changes in the working environment that may lead to loss to follow-up; 7. Factors affecting gastrointestinal function: acute or chronic primary gastrointestinal diseases such as coeliac disease, autoimmune gastritis, inflammatory bowel disease, or irritable bowel syndrome; 8. Factors affecting the gastrointestinal microbiota: gastrointestinal and respiratory tract infections, food poisoning, or antibiotic treatment within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-Motor Symptoms Scale(NMSS);Traditional Chinese Medicine Syndrome Scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS Unified Parkinson's Disease Rating Scale(MDS UPDRS);Patient Assessment of Constipation Symptoms (PAC-SYM);Pittsburgh Sleep Quality Index (PSQI); | — |
Countries
china
Contacts
Public Contactzhengyan
Jiangsu Province Hospital of TCM
Outcome results
None listed