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

• Qizhitongluo Capsule (Drug), also known as QZTL group
• Naoxintong Capsule (Drug), also known as NXT group
• Aspirin Enteric-coated Tablets (Drug)
• the routine recovery training (Behavioral)
• placebo (Drug)

Primary outcomes

• change in the Lower Extremity Fugl-Meyer score [baseline, after 4,12 weeks of treatment, after 90 days of onset.]

Secondary outcomes

• Change in Aphasia Quotient（AQ) score [baseline, after 4,12 weeks of treatment, after 90 days of onset.]
• Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90 [baseline, after 4,12 weeks of treatment, after 90 days of onset.]
• Change in the Upper Extremity Fugl-Meyer score [baseline, after 4,12 weeks of treatment, after 90 days of onset.]
• Change in the total Fugl-Meyer motor score [baseline, after 4,12 weeks of treatment, after 90 days of onset.]
• Change in the syndrome score of Qi Deficiency and Blood Stasis [baseline, after 4,12 weeks of treatment, after 90 days of onset.]
• the incidence of New-onset cardiovascular events [during the 20-weeks]
• Changes in plasma glucose and lipid concentrations and blood coagulate [baseline and after 12 weeks of treatment]
• physical examination、 laboratory tests and ECG [baseline and after 12 weeks of treatment]
• the incidence of adverse events [during the 20-weeks]
• all cause mortality [during the 20-weeks]

Other outcomes

• The modified Rankin Scale(mRS) score [baseline]
• the National Health Interview Surveys (NHISS) score [baseline]

Sex: All, ages: 35 Years to 80 Years

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.

• Zhong Wang, Ph.D., Study director, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
• Yingzhen Xie, M.D., Principal investigator, Dongzhimen Hospital, Beijing