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

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Qizhitongluo Capsule

Naoxintong Capsule

Aspirin Enteric-coated Tablets

the routine recovery training

placebo

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke,adaptive design, randomized, double-blind

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Guangxi University of Chinese Medicine
Langfang TCM Hospital
Luohe Hospital of Chinese Medicine
the First affiliated Hospital of Henan University of TCM
the affiliated Hospital to Changchun University of Chinese Medicine
201 Hospital of People's Liberation Army
Zhongshan Hospital Dalian University
Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
West China Hospital,Sichuan University
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
First Teaching Hospital of Tianjin University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Qizhitongluo Capsule

Naoxintong Capsule

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

change in the Lower Extremity Fugl-Meyer score

Secondary Outcome Measures

Change in Aphasia Quotient（AQ) score

Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90

Change in the Upper Extremity Fugl-Meyer score

Change in the total Fugl-Meyer motor score

Change in the syndrome score of Qi Deficiency and Blood Stasis

the incidence of New-onset cardiovascular events

Changes in plasma glucose and lipid concentrations and blood coagulate

physical examination、 laboratory tests and ECG

the incidence of adverse events

all cause mortality

Full Information

NCT ID

NCT01762163

First Posted

January 4, 2013

Last Updated

October 11, 2016

Sponsor

China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01762163

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic Stroke,adaptive design, randomized, double-blind

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

622 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Qizhitongluo Capsule

Arm Type

Experimental

Arm Description

Arm Title

Naoxintong Capsule

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Qizhitongluo Capsule

Other Intervention Name(s)

QZTL group

Intervention Type

Drug

Intervention Name(s)

Naoxintong Capsule

Other Intervention Name(s)

NXT group

Intervention Type

Drug

Intervention Name(s)

Aspirin Enteric-coated Tablets

Intervention Type

Behavioral

Intervention Name(s)

the routine recovery training

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

change in the Lower Extremity Fugl-Meyer score

Time Frame