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

Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke With Qi Deficiency and Blood Stasis Syndrome: a Multicenter, Randomized,Double-blind，Placebo- and Active-controlled Adaptive Study

This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.

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.