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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 13
- 主要终点
- change in the Lower Extremity Fugl-Meyer score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •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.
研究组 & 干预措施
Qizhitongluo Capsule
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.
干预措施: Qizhitongluo Capsule (Drug)
Qizhitongluo Capsule
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.
干预措施: Aspirin Enteric-coated Tablets (Drug)
Qizhitongluo Capsule
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.
干预措施: the routine recovery training (Behavioral)
Qizhitongluo Capsule
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.
干预措施: placebo (Drug)
Naoxintong Capsule
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.
干预措施: Naoxintong Capsule (Drug)
Naoxintong Capsule
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.
干预措施: Aspirin Enteric-coated Tablets (Drug)
Naoxintong Capsule
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.
干预措施: the routine recovery training (Behavioral)
Placebo
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.
干预措施: Aspirin Enteric-coated Tablets (Drug)
Placebo
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.
干预措施: the routine recovery training (Behavioral)
Placebo
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.
干预措施: placebo (Drug)
结局指标
主要结局
change in the Lower Extremity Fugl-Meyer score
时间窗: baseline, after 4,12 weeks of treatment, after 90 days of onset.
次要结局
- 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)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences