Clinical Trial to Assess the Effectiveness and to Safety of UC in the Patients with Ischemic Stroke
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003997
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
(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
(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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Korean version of Fugl-Meyer Assessment (FMA) motor function score
- Secondary Outcome Measures
Name Time Method 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