Post-stroke spasticity(PSS)
Conditions
Interventions
Treatment group:Yangnao Rujin Wan + Guideline-based standardized internal medicine treatment
Control Group:Yangnao Rujin Pill placebo + evidence-based standardized internal medicine treatment
Sponsors
Hunan Provincial Hospital of Integrated Traditional and Western Medicine (Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Western medical diagnosis meets the diagnostic criteria for cerebral infarction; (2) Patients with hemiplegia and spasticity: Brunnstrom 6-stage motor function assessment of hemiplegia at stage III or above, and Modified Ashworth Scale (MAS) for muscle tone = grade 1 and = grade 3; (3) Age = 18 years and = 80 years; gender is not restricted; (4) Patients who are conscious (GCS score = 15); (5) Onset of symptoms within 15 to 180 days; (6) No participation in other clinical trials within the past 3 months; (7) The patient or their family member has given consent and signed the informed consent form; (8) No severe diseases of the haematopoietic or endocrine systems, etc.
Exclusion criteria
Exclusion criteria: (1) History of motor dysfunction, such as rheumatoid arthritis, surgery on the limbs, joint deformities, multiple sclerosis, spinal cord injury, or neuromuscular disorders that affect limb movement; (2) History of stroke with residual limb spasticity; (3) Severe impairment of liver and kidney function (ALT > 2 times the upper limit of normal or AST > 2 times the upper limit of normal; Cr > 1.5 times the upper limit of normal); (4) Severe life-threatening conditions such as serious heart, liver, kidney, or endocrine diseases, with an expected survival time of less than 3 months; (5) Mental disorders, cognitive or emotional impairments that prevent understanding and/or compliance with the study procedures and/or follow-up; (6) Allergy to the components of Yangnao Rongjin Pills; (7) Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Ashworth Spasticity Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive Spasticity Scale;Simplified Fugl-Meyer Motor Function Assessment;National Institutes of Health Stroke Scale (NIHSS);Modified Rankin Scale;Modified Barthel Index;Surface Electromyography; | — |
Countries
China
Contacts
Public ContactXie Le
Hunan Provincial Hospital of Integrated Traditional and Western Medicine (Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Outcome results
None listed