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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762163
• Other study ID #: QZTL2013
• Secondary ID: QZTL
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2013
• Last updated: October 11, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Qizhitongluo Capsule

• Naoxintong Capsule

• Aspirin Enteric-coated Tablets

Behavioral:
• the routine recovery training

Drug:
• placebo

Locations

Country	Name	City	State
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	the affiliated Hospital to Changchun University of Chinese Medicine	Changchun	Jilin
China	Teaching Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	201 Hospital of People's Liberation Army	Dalian	Liaoning
China	Zhongshan Hospital Dalian University	Dalian	Liaoning
China	Langfang TCM Hospital	Langfang	Hebei
China	Luohe Hospital of Chinese Medicine	Luohe	Henan
China	The First Affiliated Hospital of Guangxi University of Chinese Medicine	Nanning	Guangxi
China	Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	First Teaching Hospital of Tianjin University of TCM	Tianjin
China	the First affiliated Hospital of Henan University of TCM	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The modified Rankin Scale(mRS) score		baseline	No
Other	the National Health Interview Surveys (NHISS) score		baseline	No
Primary	change in the Lower Extremity Fugl-Meyer score		baseline, after 4,12 weeks of treatment, after 90 days of onset.	No
Secondary	Change in Aphasia Quotient(AQ) score		baseline, after 4,12 weeks of treatment, after 90 days of onset.	No
Secondary	Change in Barthel Index score and proportion of subjects with Barthel Index score =90		baseline, after 4,12 weeks of treatment, after 90 days of onset.	No
Secondary	Change in the Upper Extremity Fugl-Meyer score		baseline, after 4,12 weeks of treatment, after 90 days of onset.	No
Secondary	Change in the total Fugl-Meyer motor score		baseline, after 4,12 weeks of treatment, after 90 days of onset.	No
Secondary	Change in the syndrome score of Qi Deficiency and Blood Stasis		baseline, after 4,12 weeks of treatment, after 90 days of onset.	No
Secondary	the incidence of New-onset cardiovascular events		during the 20-weeks	Yes
Secondary	Changes in plasma glucose and lipid concentrations and blood coagulate		baseline and after 12 weeks of treatment	Yes
Secondary	physical examination? laboratory tests and ECG		baseline and after 12 weeks of treatment	Yes
Secondary	the incidence of adverse events		during the 20-weeks	Yes
Secondary	all cause mortality		during the 20-weeks	Yes