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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by China Academy of Chinese Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01762163
First received: January 4, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Drug: Qizhitongluo Capsule
Drug: Naoxintong Capsule
Drug: Aspirin Enteric-coated Tablets
Behavioral: the routine recovery training
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • change in the Lower Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Aphasia Quotient(AQ) score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]
  • Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90 [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]
  • Change in the Upper Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]
  • Change in the total Fugl-Meyer motor score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]
  • Change in the syndrome score of Qi Deficiency and Blood Stasis [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]
  • the incidence of New-onset cardiovascular events [ Time Frame: during the 20-weeks ] [ Designated as safety issue: Yes ]
  • Changes in plasma glucose and lipid concentrations and blood coagulate [ Time Frame: baseline and after 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • physical examination、 laboratory tests and ECG [ Time Frame: baseline and after 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • the incidence of adverse events [ Time Frame: during the 20-weeks ] [ Designated as safety issue: Yes ]
  • all cause mortality [ Time Frame: during the 20-weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • The modified Rankin Scale(mRS) score [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • the National Health Interview Surveys (NHISS) score [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 624
Study Start Date: October 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Qizhitongluo Capsule
Other Name: QZTL group
Drug: Aspirin Enteric-coated Tablets Behavioral: the routine recovery training Drug: placebo
Active Comparator: 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.

Drug: Naoxintong Capsule
Other Name: NXT group
Drug: Aspirin Enteric-coated Tablets Behavioral: the routine recovery training
Placebo Comparator: 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.

Drug: Aspirin Enteric-coated Tablets Behavioral: the routine recovery training Drug: placebo

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762163

Contacts
Contact: Zhong Wang, Ph.D +86-10-64014411 ext 3308 zhonw@vip.sina.com
Contact: Hongli Wu, M.D. +86-10-64014411 ext 2802 holiwu@yeah.net

Locations
China, Guangxi
The First Affiliated Hospital of Guangxi University of Chinese Medicine Recruiting
Nanning, Guangxi, China, 530023
Contact: Liwu Huang    15878806668    liwuhuang5912@163.com   
Contact: Wei Chen    13978824543    chenwei8126@126.com   
China, Hebei
Langfang TCM Hospital Recruiting
Langfang, Hebei, China
Contact: Dequan Liu, Professor    15831686788    lfliudequan@163.com   
Contact: Jingjing Chang    18031603677    33804261@qq.com   
China, Henan
the First affiliated Hospital of Henan University of TCM Recruiting
Zhengzhou, Henan, China
Contact: Xinzhi Wang, Professor    +86-371-66220364    znqznq@163.com   
Contact: Yanmei Li    13764564457    liyanmei22@163.com   
China, Jilin
the affiliated Hospital to Changchun University of Chinese Medicine Recruiting
Changchun, Jilin, China
Contact: Jianjun Zhao, associate professor    +86-15948000771    Zhaojianjun8777@163.com   
Contact: Yue Wang    15844009550    2573999012@qq.com   
China, Liaoning
Zhongshan Hospital Dalian University Recruiting
Dalian, Liaoning, China
Contact: Jing He    15524587532      
Contact: Xinyi Gu    13478650197      
201 Hospital of People's Liberation Army Recruiting
Dalian, Liaoning, China
Contact: Hui Liu    18900992700    liuh2002@hotmail.com   
Contact: Xia Li       41768979@qq.com   
Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine Recruiting
Shenyang, Liaoning, China
Contact: Fuying Jiao, Professor    024-86508813    inzyjiaofuying@sina.com   
Contact: Liang Yao    15002461511    yaoliang83730@sina.com   
China, Sichuan
West China Hospital,Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Yun Qu, associate professor    +86-28-85423523    quyben@163.com   
Contact: Yi Li    13558660273    58317801@qq.com   
China
Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences Recruiting
Beijing, China
Contact: Wentao Ding, associate professor    +86-13261853981    DWTHRC@126.com   
Contact: Bo Zhang    18612180053    zhangbo886@sina.com   
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, China, 100700
Contact: Yingzhen Xie, Professor    +86-10-84013182      
Contact: Yizhan Wang    18810466346    724277231@qq.com   
First Teaching Hospital of Tianjin University of TCM Recruiting
Tianjin, China
Contact: Zhihong Meng, Professor    +86-18722699933    jy1988mzh@163.com   
Contact: Xiaoyu Dai    13012289781    huangdxy@hotmail.com   
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Study Director: Zhong Wang, Ph.D. Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences
Principal Investigator: Yingzhen Xie, M.D. Dongzhimen Hospital, Beijing
  More Information

No publications provided

Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01762163     History of Changes
Other Study ID Numbers: QZTL2013, QZTL
Study First Received: January 4, 2013
Last Updated: February 3, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by China Academy of Chinese Medical Sciences:
Ischemic Stroke,adaptive design, randomized, double-blind

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014