Efficacy and Safety of Qizhitongluo Capsule in the Recove... | NCT01762163

ID	Type	Description	Link
QZTL	Registry Identifier	QZTL

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Qizhitongluo Capsule	Experimental	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 Drug: Aspirin Enteric-coated Tablets Behavioral: the routine recovery training Drug: placebo
Naoxintong Capsule	Active Comparator	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 Drug: Aspirin Enteric-coated Tablets Behavioral: the routine recovery training
Placebo	Placebo Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
Qizhitongluo Capsule	Drug		Qizhitongluo Capsule	QZTL group
Naoxintong Capsule

Outcomes Module

Measure	Description	Time Frame
change in the Lower Extremity Fugl-Meyer score		baseline, after 4,12 weeks of treatment, after 90 days of onset.

Secondary Outcomes

Measure	Description	Time Frame
Change in Aphasia Quotient（AQ) score		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		baseline, after 4,12 weeks of treatment, after 90 days of onset.

Measure	Description	Time Frame
The modified Rankin Scale(mRS) score		baseline
the National Health Interview Surveys (NHISS) score		baseline

Eligibility Module

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.

Name	Affiliation	Role
Zhong Wang, Ph.D.	Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences	Study Director
Yingzhen Xie, M.D.	Dongzhimen Hospital, Beijing	Principal Investigator

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases