Ischemic stroke recovery period
Conditions
Interventions
Low-dose group:(2 Ginkgolide Dropping Pills + 2 Placebo Pills) per dose, twice daily, taken after meals.
High-dose group:Ginkgolide Dropping Pills, 4 pills per dose, twice daily, taken after meals.
Placebo group:Ginkgolide Dropping Pills simulant: 4 pills per dose, twice daily, take after meals.
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with confirmed ischemic stroke evidenced by clear imaging diagnostics; 2.Meeting the TCM diagnostic criteria for wind-stroke affecting the meridians, with syndrome differentiation of phlegm-stasis obstructing collaterals (TCM diagnostic criteria are established with reference to the "National Standards of the People's Republic of China: Criteria for Diagnosis and Therapeutic Efficacy of TCM Diseases and Syndromes." The syndrome differentiation criteria for phlegm-stasis obstructing collaterals adopt the "Diagnostic Scale for Syndrome Elements of Ischemic Stroke," requiring simultaneous fulfillment of phlegm-dampness syndrome and blood-stasis syndrome); 3.Aged between 18 and 75 years (inclusive); 4.National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20 (inclusive); 5.Disease course within 14 to 30 days (inclusive) after onset, representing patients in the recovery phase of stroke; 6.Patients or their legal representatives have provided informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with cerebral infarction accompanied by impaired consciousness (NIHSS score Ia item = 2 points), transient ischemic attack (TIA), or intracerebral hemorrhage after cerebral infarction; 2. Patients with mRS score = 2 points prior to the current onset; 3. Patients who have undergone vascular reperfusion therapy (e.g., intravenous thrombolysis, endovascular intervention, etc.) after the current onset; 4. Patients with hepatic or renal dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 × upper limit of normal (ULN), serum creatinine > 1.5 × ULN); 5. Patients with pre-existing mental disorders, cognitive impairment, or dementia prior to the current onset; 6. Patients with other life-threatening severe diseases with an expected survival time of less than 6 months; 7. Patients with poor glycemic or blood pressure control despite systematic treatment (glycated hemoglobin = 8.5 mmol/L; systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); 8. Patients with other conditions affecting limb motor function evaluation, including pre-existing limb motor dysfunction due to claudication, rheumatoid arthritis, gouty arthritis, etc., or neurologic deficits, peripheral neuropathy, or diabetic gangrene caused by diabetes mellitus; 9. Pregnant, breastfeeding women, or those planning pregnancy in the near future, or unwilling to use contraceptive measures; 10. Patients with allergy to ginkgo-derived drugs or foods; 11. Patients with dysphagia affecting drug intake; 12. Patients who participated in other interventional clinical studies within 30 days prior to obtaining informed consent; 13. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with mRS (Modified Rankin Scale) score =1 after 12-week treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants with mRS(Modified Rankin Scale) score =2 after 12 weeks of treatment.;The proportion of subjects with BI(Barthel Index?) scores =95 after 12 weeks of treatment.;The proportion of subjects treated for 12 weeks with BI(Barthel Index?) score =75.;Compared to baseline, the change in NIHSS(National Institute of Health Stroke Scale) scores at 4 weeks, 8 weeks, and 12 weeks of treatment.;The change in scores of Chinese medicine syndromes (phlegm-dampness syndrome, blood stasis syndrome) after 12 weeks of medication compared to baseline values.;The incidence rate of new vascular events during the study period.;Change in MoCA(Montreal Cognitive Assessment) scores compared to baseline after 12 weeks of medication.; | — |
Countries
China
Contacts
Public ContactGao Ying
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed