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Completed

NCT Number: NCT01762163

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

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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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, Guangxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qizhitongluo Capsule

Drug

Other names: QZTL group

Naoxintong Capsule

Drug

Other names: NXT group

Aspirin Enteric-coated Tablets

Drug

the routine recovery training

Behavioral

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2013
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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