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

NCT01762163 | Completed Phase 4 DMC

• 2 other identifiers: QZTL2013QZTL
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 13

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke,adaptive design, randomized, double-blind

Outcome Measures

Primary Outcomes (1)

• change in the Lower Extremity Fugl-Meyer score

  baseline, after 4,12 weeks of treatment, after 90 days of onset.

Secondary Outcomes (10)

• 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.

• Change in the Upper Extremity Fugl-Meyer score

  baseline, after 4,12 weeks of treatment, after 90 days of onset.

• Change in the total Fugl-Meyer motor score

  baseline, after 4,12 weeks of treatment, after 90 days of onset.

• Change in the syndrome score of Qi Deficiency and Blood Stasis

  baseline, after 4,12 weeks of treatment, after 90 days of onset.

Other Outcomes (2)

• The modified Rankin Scale(mRS) score

  baseline

• the National Health Interview Surveys (NHISS) score

  baseline

Study Arms (3)

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

Interventions

Qizhitongluo Capsule DRUG

Also known as: QZTL group

Qizhitongluo Capsule

Naoxintong Capsule DRUG

Also known as: NXT group

Naoxintong Capsule

Aspirin Enteric-coated Tablets DRUG

Naoxintong Capsule; Placebo; Qizhitongluo Capsule

the routine recovery training BEHAVIORAL

Naoxintong Capsule; Placebo; Qizhitongluo Capsule

placebo DRUG

Placebo; Qizhitongluo Capsule

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ NIHSS score\<20;
• Patient is willing to participate voluntarily and to sign a written patient informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (13)

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Nanning, Guangxi, 530023, China

Location

Langfang TCM Hospital

Langfang, Hebei, China

Location

Luohe Hospital of Chinese Medicine

Luohe, Henan, 462000, China

Location

the First affiliated Hospital of Henan University of TCM

Zhengzhou, Henan, China

Location

the affiliated Hospital to Changchun University of Chinese Medicine

Changchun, Jilin, China

Location

201 Hospital of People's Liberation Army

Dalian, Liaoning, China

Location

Zhongshan Hospital Dalian University

Dalian, Liaoning, China

Location

Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Location

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Location

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, 100700, China

Location

Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences

Beijing, China

Location

First Teaching Hospital of Tianjin University of TCM

Tianjin, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

naoxintong

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 7, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

CN (13)