Ischemic stroke
Conditions
Interventions
Experimental Group:Qingre Huatan Decoction + Guideline-based standardized treatment
Control Group:Guideline for standardized treatment
Sponsors
Dongzhimen Hospital Affliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for ischemic stroke; (2) Meets the diagnostic criteria for phlegm-heat syndrome; (3) Within 72 hours of onset; (4) 18 years old = age = 80 years old, regardless of gender; (5) NIHSS score between 4 and 25 points (with motor function = 2 points); (6) The patient or their legal representative has given informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to the components of the traditional Chinese medicine compound used in the trial; 2. Patients who have received or areto receive intravenous thrombolysis or endovascular intervention (including endovascular mechanical thrombectomy, arterial thrombolysis, and angioplasty); 3. Stroke patients confirmed to be caused by brain tumors, brain trauma, hematological diseases, infectious diseases, genetic diseases, or rheumatic immune diseases; 4. Patients with a history of stroke and residual sequelae affecting outcome assessment, i.e., mRS score =2 points prior to the onset of the current stroke; 5. Patients with comorbidities such as claudication, osteoarthritis, rheumatoid arthritis, or gouty arthritis, which impair limb mobility and affect neurological examination; 6. Patients with severe liver or kidney dysfunction (liver dysfunction refers to ALT or AST >2 times the upper limit of normal, and kidney dysfunction refers to Cr >2 times the upper limit of normal); 7. Patients with other life-threatening severe diseases with an expected survival time of less than 3 months; 8. Patients with other diseases that may limit neurological function evaluation or affect patient follow-up; 9. Pregnant women, those planning pregnancy, or breastfeeding women; 10. Patients currently participating in other interventional clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of enrolled patients achieving excellent functional outcomes (mRS 0-1) at 90 days.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of neurological deficits at 14 days after enrollment compared to baseline.;Comparison of Activities of Daily Living (ADLs) within the group over 14 days.;Change in phlegm-heat syndrome scores after 14 days of enrollment compared to baseline.;Changes in scoring of various Chinese medicine syndrome elements after 14 days of enrollment.;Comparison of Patient-Reported Outcomes at 14 Days Post-Enrollment;The proportion of enrolled patients achieving good functional outcomes at 90 days (mRS 0-2 points).;Distribution of mRS scores among enrolled participants at 90 days.;Enrollment 90-day Activities of Daily Living (ADLs);Change in quality of life assessment at 90 days post-enrollment.; | — |
Countries
China
Contacts
Public ContactGao Ying
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed