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Not yet recruiting NCT07163702

Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke

Phase II Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-dose Xinglou Chengqi granules, Low-dose Xinglou Chengqi granules and placebo.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke (EXACT): a Multi-center, Randomized, Double-blinded, Dose-exploration Ⅱa Trial

Overview

This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.

Interventions

  • Drug High-dose Xinglou Chengqi granules
    Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
  • Drug Low-dose Xinglou Chengqi granules and placebo
    Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.

Primary outcome measures

  • The change of NIHSS score from baseline to day 14. [Time frame: Baseline and Day 14.]
Secondary outcome measures (5)
  • The proportions of patients with mRS ≤ 2 or mRS ≤ 1. [Time frame: Day 30, Day 60 and Day 90.]
  • The change of NIHSS score [Time frame: Day 7, day 30, day 60, day 90.]
  • The proportion of patients with Barthel Index score ≥ 95 or ≥ 75. [Time frame: day 7, day 14, day 30, day 60, day 90.]
  • The change of EQ-5D score. [Time frame: day 7, day 14, day 30, day 60, day 90.]
  • The incidence of new cardiovascular events. [Time frame: day 7, day 14, day 30, day 60, day 90.]

Eligibility criteria

Inclusion criteria

  • Inpatients diagnosed with acute ischemic stroke.
  • Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome.
  • Acute ischemic stroke within 7 days after onset.
  • 6 ≤ NIHSS <20.
  • Aged 18-70 years, male or female.
  • The patient or representative has signed informed consent.

Exclusion criteria

  • Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
  • NIHSS Ⅰa ≥2.
  • Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
  • Received or planned thrombolysis or endovascular therapy after onset.
  • Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase > 2.5 times the upper limit of normal value, serum creatinine > 1.5 times the upper limit of normal value)
  • With cancers or uncontrolled diabetes.
  • The expected survival time is less than 3 months.
  • Patients who have used other traditional Chinese medicine for treating acute ischemic stroke since stroke onset.
  • Patients with severe mental disorders, dementia, or other comorbid diseases that may affect neurological function examination.
  • With a history of alcohol or drug abuse or drug dependence.
  • Those known to be allergic to the investigated drug or its components.
  • Pregnancy, potential pregnancy, or breastfeeding.
  • Currently participating in other clinical trials during the past 3 months.
  • Those who are judged by researchers to have poor compliance or are not suitable for participating in this study for any other reason.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Dongzhimen Hospital, Beijing University of Chinese Medicine — Richmond

Identifiers

NCT: NCT07163702 · 2025DZMEC-251-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗