Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

Recruiting

Phase 4 Results N/A

Update History

18 Nov '17
The description was updated.
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The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention,which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers,who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.
Old
The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention,which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers,who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.
The eligibility criteria were updated.
New
Inclusion Criteria: - Adult volunteers aged ≤ 90 years old, ≥18 years old; - Conforming to the diagnostic criteria of cerebral infarction under the 2010 version of Chinese Guidelines for Treatment of Acute Ischemic Stroke; - Conforming to diagnostic criteria of the stasis type of TCM on the ischemic stroke; - The onset of acute cerebral infarction ≥ 10 days; - Consciousness awake; - Volunteers agree to accept the program and sign informed consent. Exclusion Criteria: - Excluding the patients of the yin deficiency type of ischemic stroke.The diagnostic criteria of Yin deficiency type of ischemic stroke is that sudden onset of disease;being signs or symptoms of of neurological deficit;CT or MRI examination showing intracranial ischemic lesions;Scarlet tongue; - The volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up; - Psychiatric patients; - Pregnants and lactating women; - Volunteers in other clinical trials; - Volunteers who are not suitable for this clinical trial according to the researchers for other reasons.
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Inclusion Criteria: - Adult volunteers aged ≤ 90 years old, ≥18 years old; - Conforming to the diagnostic criteria of cerebral infarction under the 2010 version of Chinese Guidelines for Treatment of Acute Ischemic Stroke; - Conforming to diagnostic criteria of the stasis type of TCM on the ischemic stroke; - The onset of acute cerebral infarction ≥ 10 days; - Consciousness awake; - Volunteers agree to accept the program and sign informed consent. Exclusion Criteria: - Excluding the patients of the yin deficiency type of ischemic stroke.The diagnostic criteria of Yin deficiency type of ischemic stroke is that sudden onset of disease;being signs or symptoms of of neurological deficit;CT or MRI examination showing intracranial ischemic lesions;Scarlet tongue; - The volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up; - Psychiatric patients; - Pregnants and lactating women; - Volunteers in other clinical trials; - Volunteers who are not suitable for this clinical trial according to the researchers for other reasons.
21 Jun '17
The gender criteria for eligibility was updated to "All."
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai seventh People's Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Putuo Central Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Zhongshan Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Huashan Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai fifth People's Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Tongren Hospital affliated to Shanghai Jiao Tong University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Tongji Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Chinese Medicine Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Tenth People's Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Hospital of Integrative Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Dongfang Hospital affliated to Tongji University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Pudong Gong Li Hospital of Shanghai.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Changning Tongren Hospital of Shanghai.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Changhai Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Pudong Hospital of Traditional Chinese Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at East Branch of Shanghai sixth People's Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Qingpu Branch of Zhongshan Hospital affliated to Fudan University.
22 Apr '16
A location was updated in Shanghai.
New
The overall status was updated to "Completed" at Shanghai seventh People's Hospital.
A location was updated in Shanghai.
New
The overall status was updated to "Completed" at North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Putuo Central Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Zhongshan Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Huashan Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai fifth People's Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Tongren Hospital affliated to Shanghai Jiao Tong University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Tongji Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Chinese Medicine Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Tenth People's Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai Hospital of Integrative Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Dongfang Hospital affliated to Tongji University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Pudong Gong Li Hospital of Shanghai.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Changning Tongren Hospital of Shanghai.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Changhai Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Pudong Hospital of Traditional Chinese Medicine.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at East Branch of Shanghai sixth People's Hospital.
A location was updated in Shanghai.
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The overall status was updated to "Completed" at Qingpu Branch of Zhongshan Hospital affliated to Fudan University.
A location was updated in Shanghai.
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The overall status was updated to "Recruiting" at Shanghai third People's Hospital affliated to Shanghai Jiao Tong University.