Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke
NCT ID: NCT01762163
Last Updated: 2016-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
622 participants
INTERVENTIONAL
2013-10-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risk Assessment Model for Ischemic Stroke Endpoint Events
NCT03174535
Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment
NCT04301466
Tongxinluo Capsule in Ischemic Stroke Patients（TISS)
NCT01919671
Effectiveness and Safety of Yiqitongluo Granule for Stroke
NCT02604654
Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM
NCT02334969
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Qizhitongluo Capsule
Aspirin Enteric-coated Tablets
the routine recovery training
placebo
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.
Naoxintong Capsule
Aspirin Enteric-coated Tablets
the routine recovery training
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.
Aspirin Enteric-coated Tablets
the routine recovery training
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Qizhitongluo Capsule
Naoxintong Capsule
Aspirin Enteric-coated Tablets
the routine recovery training
placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
35 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhong Wang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhong Wang, Ph.D.
Role: STUDY_DIRECTOR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Yingzhen Xie, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital, Beijing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Langfang TCM Hospital
Langfang, Hebei, China
Luohe Hospital of Chinese Medicine
Luohe, Henan, China
the First affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
the affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China
201 Hospital of People's Liberation Army
Dalian, Liaoning, China
Zhongshan Hospital Dalian University
Dalian, Liaoning, China
Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
Shenyang, 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
Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
Beijing, , China
First Teaching Hospital of Tianjin University of TCM
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QZTL
Identifier Type: REGISTRY
Identifier Source: secondary_id
QZTL2013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.