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NCT Number: NCT07163702

Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Richmond, British Columbia, V7E 6J1, Canada

Location contact

Xinxing Lai, M.D.

CONTACT

[email protected]

+8615901111280

Ying Gao, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

High-dose Xinglou Chengqi granules

Drug

Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.

Other names: Guidelines-based standard care

Low-dose Xinglou Chengqi granules and placebo

Drug

Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.

Other names: Guidelines-based standard care

Primary outcomes

  1. The change of NIHSS score from baseline to day 14.

    Time frame: Baseline and Day 14.

    The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups.

Secondary outcomes

  1. The proportions of patients with mRS ≤ 2 or mRS ≤ 1.

    Time frame: Day 30, Day 60 and Day 90.

    The proportions of patients with modified Rankin Scale (mRS) ≤ 2 or mRS ≤ 1 will be analyzed between groups.

  2. The change of NIHSS score

    Time frame: Day 7, day 30, day 60, day 90.

    The change of NIHSS score will be analyzed at days 7, 30, 60, and 90.

  3. The proportion of patients with Barthel Index score ≥ 95 or ≥ 75.

    Time frame: day 7, day 14, day 30, day 60, day 90.

    The proportion of patients with Barthel Index score ≥ 95 or ≥ 75 will be analyzed at days 7, 14, 30, 60, and 90.

  4. The change of EQ-5D score.

    Time frame: day 7, day 14, day 30, day 60, day 90.

    The change of EQ-5D score from baseline to days 7, 14, 30, 60, and 90 will be analyzed between groups.

  5. The incidence of new cardiovascular events.

    Time frame: day 7, day 14, day 30, day 60, day 90.

    The incidence of new cardiovascular events will be analyzed at day 7, 14, 30, 60, and 90.

Study contacts

Contact information is provided by the study sponsor or research team.

Xinxing Lai, M.D.

CONTACT

[email protected]

+8615901111280

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study title

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

Acronym: EXACT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

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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