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CompletedNCT01762163Updated Oct 12, 2016

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

A Phase 4 interventional study of Qizhitongluo Capsule and Naoxintong Capsule in Ischemic Stroke, sponsored by China Academy of Chinese Medical Sciences. Completed at 13 sites in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-12.

Sponsored by China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
622
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Ischemic Stroke

Keywords

  • Ischemic Stroke,adaptive design, randomized, double-blind
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 622 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
622 participants (actual)

Study arms

  • Experimental
    Qizhitongluo Capsule

    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

  • Active comparator
    Naoxintong Capsule

    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 comparator
    Placebo

    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

  • DrugQizhitongluo Capsule

    Also known as: QZTL group

  • DrugNaoxintong Capsule

    Also known as: NXT group

  • DrugAspirin Enteric-coated Tablets
  • Behavioralthe routine recovery training
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. change in the Lower Extremity Fugl-Meyer score

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

Secondary outcomes

  1. Change in Aphasia Quotient（AQ) score

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

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

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

  3. Change in the Upper Extremity Fugl-Meyer score

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

  4. Change in the total Fugl-Meyer motor score

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

  5. Change in the syndrome score of Qi Deficiency and Blood Stasis

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

  6. the incidence of New-onset cardiovascular events

    Time frame: during the 20-weeks

  7. Changes in plasma glucose and lipid concentrations and blood coagulate

    Time frame: baseline and after 12 weeks of treatment

  8. physical examination、 laboratory tests and ECG

    Time frame: baseline and after 12 weeks of treatment

  9. the incidence of adverse events

    Time frame: during the 20-weeks

  10. all cause mortality

    Time frame: during the 20-weeks

Other outcomes

  1. The modified Rankin Scale(mRS) score

    Time frame: baseline

  2. the National Health Interview Surveys (NHISS) score

    Time frame: baseline

07

Study locations

13 sites
  • The First Affiliated Hospital of Guangxi University of Chinese Medicine
    Nanning, Guangxi 530023, China
  • Langfang TCM Hospital
    Langfang, Hebei, China
  • Luohe Hospital of Chinese Medicine
    Luohe, Henan 462000, China
  • the First affiliated Hospital of Henan University of TCM
    Zhengzhou, Henan, China
  • the affiliated Hospital to Changchun University of Chinese Medicine
    Changchun, Jilin, China
  • 201 Hospital of People's Liberation Army
    Dalian, Liaoning, China
  • Zhongshan Hospital Dalian University
    Dalian, Liaoning, China
  • Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
    Shenyang, Liaoning, China
  • Teaching Hospital of Chengdu University of Traditional Chinese Medicine
    Chengdu, Sichuan 610075, China
  • West China Hospital,Sichuan University
    Chengdu, Sichuan, China
  • Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
    Beijing, 100700, China
  • Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
    Beijing, China
  • First Teaching Hospital of Tianjin University of TCM
    Tianjin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01762163
Lead sponsor
China Academy of Chinese Medical Sciences
Responsible party
Zhong Wang (Professor, China Academy of Chinese Medical Sciences) — Principal investigator
First posted
Jan 7, 2013
Start date
Oct 2013
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Oct 12, 2016

Study contacts

Zhong Wang, Ph.D.
study director · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Yingzhen Xie, M.D.
principal investigator · Dongzhimen Hospital, Beijing

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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