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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences
• Treatments: Aspirin

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.