Clinical trial NCT01762163: Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke,adaptive design, randomized, double-blind
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 622
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: change in the Lower Extremity Fugl-Meyer score
timeFrame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Secondary outcomes:
measure: Change in Aphasia Quotient（AQ) score
timeFrame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
measure: Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90
timeFrame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
measure: Change in the Upper Extremity Fugl-Meyer score
timeFrame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
measure: Change in the total Fugl-Meyer motor score
timeFrame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
measure: Change in the syndrome score of Qi Deficiency and Blood Stasis
timeFrame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
measure: the incidence of New-onset cardiovascular events
timeFrame: during the 20-weeks
measure: Changes in plasma glucose and lipid concentrations and blood coagulate
timeFrame: baseline and after 12 weeks of treatment
measure: physical examination、 laboratory tests and ECG
timeFrame: baseline and after 12 weeks of treatment
measure: the incidence of adverse events
timeFrame: during the 20-weeks
measure: all cause mortality
timeFrame: during the 20-weeks
Other outcomes:
measure: The modified Rankin Scale(mRS) score
timeFrame: baseline
measure: the National Health Interview Surveys (NHISS) score
timeFrame: baseline
Locations:
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Langfang
country: China
facility: Langfang TCM Hospital
state: Hebei
city: Luohe
country: China
facility: Luohe Hospital of Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: the First affiliated Hospital of Henan University of TCM
state: Henan
city: Changchun
country: China
facility: the affiliated Hospital to Changchun University of Chinese Medicine
state: Jilin
city: Dalian
country: China
facility: 201 Hospital of People's Liberation Army
state: Liaoning
city: Dalian
country: China
facility: Zhongshan Hospital Dalian University
state: Liaoning
city: Shenyang
country: China
facility: Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of TCM
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, Ph.D.
role: STUDY_DIRECTOR
affiliation: Dongzhimen Hospital, Beijing
name: Yingzhen Xie, M.D.
role: PRINCIPAL_INVESTIGATOR
References: