Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke
Phase 4
Completed
- Conditions
- Ischemic Stroke
- Interventions
- Drug: Qizhitongluo CapsuleDrug: Naoxintong CapsuleBehavioral: the routine recovery trainingDrug: placebo
- Registration Number
- NCT01762163
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 622
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Naoxintong Capsule Aspirin Enteric-coated Tablets 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. Qizhitongluo Capsule Aspirin Enteric-coated Tablets 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. Placebo Aspirin Enteric-coated Tablets 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. Qizhitongluo Capsule 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. Naoxintong Capsule the routine recovery training 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. Qizhitongluo Capsule the routine recovery training 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. Qizhitongluo Capsule placebo 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. Placebo 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. Naoxintong Capsule 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. Placebo the routine recovery training 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.
- Primary Outcome Measures
Name Time Method change in the Lower Extremity Fugl-Meyer score baseline, after 4,12 weeks of treatment, after 90 days of onset.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (13)
The First Affiliated Hospital of Guangxi University of Chinese Medicine
🇨🇳Nanning, Guangxi, China
the affiliated Hospital to Changchun University of Chinese Medicine
🇨🇳Changchun, Jilin, China
Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
🇨🇳Beijing, China
First Teaching Hospital of Tianjin University of TCM
🇨🇳Tianjin, China
the First affiliated Hospital of Henan University of TCM
🇨🇳Zhengzhou, Henan, China
Zhongshan Hospital Dalian University
🇨🇳Dalian, Liaoning, China
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
🇨🇳Beijing, China
Langfang TCM Hospital
🇨🇳Langfang, Hebei, China
Luohe Hospital of Chinese Medicine
🇨🇳Luohe, Henan, China
Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
🇨🇳Shenyang, Liaoning, China
201 Hospital of People's Liberation Army
🇨🇳Dalian, Liaoning, China