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

China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke

Treatments: Behavioral: the routine recovery training; Drug: Aspirin Enteric-coated Tablets; Drug: Qizhitongluo Capsule; Drug: Naoxintong Capsule; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01762163

QZTL2013

QZTL (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 622 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

622 participants in 3 patient groups, including a placebo group

Qizhitongluo Capsule

Experimental group

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.

Treatment:

Drug: Aspirin Enteric-coated Tablets

Drug: Qizhitongluo Capsule

Drug: placebo

Behavioral: the routine recovery training

Naoxintong Capsule

Active Comparator group

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:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks.

Treatment:

Drug: Aspirin Enteric-coated Tablets

Drug: Naoxintong Capsule

Behavioral: the routine recovery training

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Aspirin Enteric-coated Tablets

Drug: placebo

Behavioral: the routine recovery training