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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Qizhitongluo Capsule
* Drug: Naoxintong Capsule
* Drug: Aspirin Enteric-coated Tablets
* Behavioral: the routine recovery training
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qizhitongluo Capsule<br>Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal（placebo was taken only after lunch, and Qizhitongluo Capsule was taken after breakfast and supper)for 12 weeks. | Drug: Qizhitongluo Capsule<br> <br> * Other names: QZTL group;Drug: Aspirin Enteric-coated Tablets<br> <br> Behavioral: the routine recovery training<br> <br> Drug: placebo<br> <br> |
| Active Comparator: Naoxintong Capsule<br>Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night; the routine recovery training. intervention treatment:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks. | Drug: Naoxintong Capsule<br> <br> * Other names: NXT group;Drug: Aspirin Enteric-coated Tablets<br> <br> Behavioral: the routine recovery training<br> <br> |
| Placebo Comparator: Placebo<br>Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night and the routine recovery training. intervention treatment:placebo capsule was administered orally four capsules each time, three times a day after each meal for 12 weeks. | Drug: Aspirin Enteric-coated Tablets<br> <br> Behavioral: the routine recovery training<br> <br> Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the Lower Extremity Fugl-Meyer score |  | baseline, after 4,12 weeks of treatment, after 90 days of onset. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke,adaptive design, randomized, double-blind