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

This study has been completed.
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: October 11, 2016
Last verified: October 2016
  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
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

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. ]

Secondary Outcome Measures:
  • Change in Aphasia Quotient(AQ) score [ Time Frame: 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 [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
  • Change in the Upper Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
  • Change in the total Fugl-Meyer motor score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
  • 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. ]
  • the incidence of New-onset cardiovascular events [ Time Frame: during the 20-weeks ]
  • Changes in plasma glucose and lipid concentrations and blood coagulate [ Time Frame: baseline and after 12 weeks of treatment ]
  • physical examination、 laboratory tests and ECG [ Time Frame: baseline and after 12 weeks of treatment ]
  • the incidence of adverse events [ Time Frame: during the 20-weeks ]
  • all cause mortality [ Time Frame: during the 20-weeks ]

Other Outcome Measures:
  • The modified Rankin Scale(mRS) score [ Time Frame: baseline ]
  • the National Health Interview Surveys (NHISS) score [ Time Frame: baseline ]

Enrollment: 622
Study Start Date: October 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01762163

Locations
China, Guangxi
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China, 530023
China, Hebei
Langfang TCM Hospital
Langfang, Hebei, China
China, Henan
Luohe Hospital of Chinese Medicine
Luohe, Henan, China, 462000
the First affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
China, Jilin
the affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China
China, Liaoning
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
China, Sichuan
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610075
West China Hospital,Sichuan University
Chengdu, Sichuan, China
China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, China, 100700
Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
Beijing, China
First Teaching Hospital of Tianjin University of TCM
Tianjin, China
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

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: October 11, 2016

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

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

ClinicalTrials.gov processed this record on January 19, 2017