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

Completed

Phase 4 Results N/A

Update History

13 Oct '16
A location was updated in Nanning.
New
The overall status was removed for The First Affiliated Hospital of Guangxi University of Chinese Medicine.
A location was updated in Langfang.
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The overall status was removed for Langfang TCM Hospital.
A location was updated in Zhengzhou.
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The overall status was removed for the First affiliated Hospital of Henan University of TCM.
A location was updated in Changchun.
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The overall status was removed for the affiliated Hospital to Changchun University of Chinese Medicine.
A location was updated in Dalian.
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The overall status was removed for 201 Hospital of People's Liberation Army.
A location was updated in Dalian.
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The overall status was removed for Zhongshan Hospital Dalian University.
A location was updated in Shenyang.
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The overall status was removed for Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine.
A location was updated in Chengdu.
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The overall status was removed for West China Hospital,Sichuan University.
A location was updated in Beijing.
New
The overall status was removed for Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine.
A location was updated in Beijing.
New
The overall status was removed for Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences.
A location was updated in Tianjin.
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The overall status was removed for First Teaching Hospital of Tianjin University of TCM.
22 Mar '16
The Summary of Purpose was updated.
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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.
Old
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.
The eligibility criteria were updated.
New
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.
Old
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.
5 Feb '14
Trial name was updated.
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Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke
The Summary of Purpose was updated.
New
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.
Old
A randomized double-blind controlled study to compare the efficacy of Qizhitongluo Capsule with that of Naoxintong Capsule and placebo in the treatment of ischemic stroke patients in recovary phase.
detailed_description not implemented.
The eligibility criteria were updated.
New
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.
Old
Inclusion Criteria: Clinical diagnosis of ischemic stroke in recovery phase,according to the chinse guidlines for the diagnosis and treatment of acute ischemic stroke 2010. Clinical diagnosis of the Chinese medical syndrome of qi dificiency and blood stasis. the interval from the onset symptoms to recruitment was 15-28days. FMscore <90 or AQ<93.8 and clinical diagnosis of aphasia. Clinical diagnosis of cerebral anterior circulation obstruction. 4≤NIHSS<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 drug. 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 stucture 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. Prior disable patients(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. -
A location was updated in Langfang.
New
The overall status was removed for Langfang TCM Hospital.
A location was updated in Zhengzhou.
New
The overall status was removed for the First affiliated Hospital of Henan University of TCM.
A location was updated in Changchun.
New
The overall status was removed for the affiliated Hospital to Changchun University of Chinese Medicine.
A location was updated in Chengdu.
New
The overall status was removed for West China Hospital,Sichuan University.
A location was updated in Beijing.
New
The overall status was removed for Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences.
A location was updated in Beijing.
New
The overall status was removed for Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine.
A location was updated in Tianjin.
New
The overall status was removed for First Teaching Hospital of Tianjin University of TCM.