Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Age≥35 years and <80 years;
- Diagnosis of ischemic stroke in recovery phase, according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2010;
- Diagnosis of ischemic stroke with qi deficiency and blood stasis syndrome;
- The interval from the onset to recruitment was 15-28 days;
- FM score <90 or AQ<93.8 and diagnosis of aphasia;
- Diagnosis of cerebral anterior circulation obstruction;
- 4≤ NIHSS score<20;
- Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria

- Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.) on CT or MRI.
- Known history of allergy or suspected allergic to the study drugs.
- Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
- Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
- Cerebral embolism caused by cerebral tumor, cerebral trauma, cerebral parasitosis, rheumatic heart disease, coronary heart disease or other cardiac diseases complicated with atrial fibrillation.
- Prestroke score on the mRS ≥2.
- Space-occupying lesions, CT or MRI revealed midline structure shift; CT revealed that massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery.
- Disable patients prescribed by law(blind, deaf, dumb, mental retardation, mental disorders and physical disabilities which due to other causes affect neural function deficient scale).
- Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
- Suspected addicted into alcohol or drug abuse; with severe complications that would make the condition more complicated assessed by the investigator.
- Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent.
- Patient who is participating in other trials or has been participated in other trials in recent 3 months.