Recovery period of cerebral infarction (meridians, wind, phlegm, stasis, blood paralysis and obstruction of the vein pattern during stroke)
Conditions
Interventions
Test group:Tiandan Tongluo capsules, 5 capsules/time, 3 times/day, oral
Fentong suppository capsule simulant, 3 capsules/time, 3 times/day, oral
Control group:Capsules, 3 capsules/time, 3 times/day, oral
Tiandan Tongluo capsule simulant, 5 capsules/time, 3 times/day, oral
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) The onset of this disease meets the diagnostic criteria of ischemic stroke in Western medicine; (2) The onset of this disease meets the diagnostic criteria for meridians in stroke (cerebral infarction) in traditional Chinese medicine; (3) Those whose course of illness is 15-42 days (including 15 and 42 days) after the onset of the disease; (4) Those who have a history of stroke for the first time or in the past, but the mRS score before the onset of this disease is 0~1 points; (5) TCM syndrome differentiation is wind, phlegm, stasis, blood paralysis, obstruction of vein pattern; (6) Aged 18-85 years old (inclusive18 and 85 years old); (7) 7 points= neurological deficit score = 22 points; (8) Before participating in the screening, the patient or his legal representative has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Head CT or MRI for the diagnosis of intracranial hemorrhagic disorders, including postcerebral infarction hemorrhage, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, brain tumors, traumatic brain injury; (2) Cerebral infarction with impaired consciousness (NIHSS score Ia=1 point); (3) Those who are clinically considered to have cardiogenic cerebral embolism (with a history of heart valves or atrial fibrillation and/or atrial fibrillation on electrocardiogram during screening); (4) Patients who have received or intend to receive intravenous thrombolysis or endovascular interventional therapy (including intravascular mechanical thrombolysis, arterial thrombolysis, and angioplasty); (5) Those who have dysphagia and affect the taking of medicine; (6) Patients with abnormal clinical laboratory tests: ALT and AST = 2.5 times the upper limit of normal, and Cr > upper limit of normal; (7) Inability to understand and/or comply with study procedures due to severe psychiatric, cognitive, or emotional disorders; (8) History of bleeding from major organs (such as cerebral hemorrhage, gastrointestinal bleeding, etc.) within 1 month; (9) Those with other diseases that affect limb function, such as limb activity dysfunction caused by claudication, rheumatoid arthritis, gouty arthritis, poliomyelitis sequelae before treatment, which may affect the evaluation of neurological function, and those who cannot complete daily activities independently due to other diseases that seriously affect the evaluation of efficacy; (10) Severe life-threatening comorbidities, life expectancy < 3 months; (11) Male patients and their spouses are unable to use reliable contraceptive measures during the trial; (12) Women who are pregnant, lactating or have a recent birth plan; (13) Suspected or confirmed history of alcohol and drug abuse within 6 months before the onset of the disease; (14) Those who know or suspect allergies to the drugs in this test or those who are allergic; (15) Those who have participated in other clinical trials in the past 3 months; (16) Other conditions that, in the judgment of the investigator, reduce the likelihood of enrollment or complicate enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in NIHSS score at 12 weeks of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS score of =1 after 12 weeks of medication;Proportion of participants with an mRS score of =2 after 12 weeks of medication;The proportion of subjects with a BI score of =95 after 12 weeks of taking the drug;Proportion of subjects with a BI score of =75 after 12 weeks of taking the drug;;The BI single score value after 12 weeks of taking the drug;The change from baseline in the individual score of the NIHSS score scale (items 5 and 6) after 12 weeks of taking the drug;The change value of the total score of TCM syndrome (internal stroke, phlegm-dampness, blood stasis pattern) from baseline after 12 weeks of taking the drug;The change from baseline in the score of TCM single syndrome (internal stroke, phlegm dampness, blood stasis pattern) at 12 weeks of taking the drug;Incidence of new vascular events during the study period; | — |
Countries
China
Contacts
Public ContactCai Yefeng
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed