None listed
Conditions
Interventions
Drug : For both arms, subjects will take Uwhangchungsimwon or placebo for 30 days.
A. UC group
Taking Uwhangchungshimwon(Yongpyo Wonbang Woohwangchungsimwon, Iksu Pharmaceutical Co.,Ltd) 3.75g onc
Sponsors
Kyung Hee University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women who are not pregnant nor breastfeeding, aged 19 to 80 years (2) Patients diagnosed with acute ischemic stroke in brain image(MR or CT) (3) Patients participating within 90 days of the onset (4) Patients with upper or lower limb weakness (Fugl-Meyer Assessment (FMA) motor score = 55 and 1= Medical Research Council Scale score (at least one arm or leg motor power grade) =4) (5) Patients with mild to moderate ischemic stroke (4= Korean version of the National Institute of Health Stroke Scale (K-NIHSS) score =15) (6) modified Rankin Scale (mRS) score before the recent ischemic stroke =1 (7) Subject who have no communication problems and voluntary agree to participate
Exclusion criteria
Exclusion criteria: (1) Patients with motor weakness caused by previous stroke (2) Patients diagnosed with degenerative brain disease(e.g., Parkinson's disease, Alzheimer's disease) (3) Patients diagnosed with hemorrhagic stroke(intracranial hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage) in brain image(MR or CT) (4) Taking amphetamine, Selective Serotonin Reuptake Inhibitors(SSRI), or antipsychotic medication (5) Patients with other brain disease (e.g., brain tumor, traumatic brain injury, arteriovenous malformation, moyamoya disease, and ischemic stroke caused by these disease, etc.) (6) Previous history of brain surgery (7) Patients who already have motor weakness due to other disease (8) Unstable vital signs at screening (e.g., systolic blood pressure (sBP) =160mmHg, even though taking antihypertensive drugs) (9) Serious disease(e.g., liver disease, kidney disease, severe heart failure( = New York Heart Association classification (NYHA) Class III), etc.) (10) Taking drugs that can cause liver or renal dysfunction (11) Patients who diagnosed or treated cancer within 6 months (12) Taking other herbal medicines within 4 weeks before participating in the clinical trial (13) Blood test meets the following criteria: 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level = x2 of normal range 2) Creatinine > 2.0mg/dL 3) Hemoglobin < 10g/dL, Hct < 25%, Platelet < 100,000/mm3 (14) Participation in other clinical studies within 30 days (15) Participants who are judged by investigator to be nonconformity for participation in the trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean version of Fugl-Meyer Assessment (FMA) motor function score | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FMA score according to baseline Fugl-Meyer Assessment (FMA) severity;Changes in Fugl-Meyer Assessment (FMA) score according to vascular territories of ischemic stroke;Changes in Fugl-Meyer Assessment (FMA) score according to start date of taking Uwhangcheongshimwon (UC) after onset;Changes in Fugl-Meyer Assessment (FMA) score according to risk factors;Korean version of the National Institutes of Health Stroke Scale (K-NIHSS) score;Korean version of the modified Rankin Scale (K-mRS) score;Korean version of the modified Barthel Index (K-MBI) score;Stroke Specific Quality of Life Scale (SS-QOL);Fugl-Meyer Assessment (FMA) score according to Cold-Heat Patternization;EQ-5D-5L (EuroQoL Five-Dimension Five-Level);Visual analogue scale of Treatment Satisfaction;Economic evaluation;Adverse reaction evaluation;Drug compliance evaluation;Beck Depression Inventory;Fatigue Assessment Scale;Fatigue Severity Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungwon Kwon
Kyung Hee University Oriental Medical Center
Outcome results
None listed