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Clinical Trials in Canada / NCT07163702
Starting soon Phase 2

Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke

NCT07163702 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2025-10-01
Last updated
2025-09-09

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

High-dose Xinglou Chengqi granulesLow-dose Xinglou Chengqi granules and placebo

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

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Inpatients diagnosed with acute ischemic stroke. 2. Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome. 3. Acute ischemic stroke within 7 days after onset. 4. 6 ≤ NIHSS \<20. 5. Aged 18-70 years, male or female. 6. The patient or representative has signed informed consent. Exclusion Criteria: 1. Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc. 2. NIHSS Ⅰa ≥2. 3. Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 ) 4. Received or planned thrombolysis or endovascular therapy after onset. 5. 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) 6. With cancers or uncontrolled diabetes. 7. The expected survival time is less than 3 months. 8. Patients who have used other traditional Chinese medicine for treating acute ischemic stroke since stroke onset. 9. Patients with severe mental disorders, dementia, or other comorbid diseases that may affect neurological function examination. 10. With a history of alcohol or drug abuse or drug dependence. 11. Those known to be allergic to the investigated drug or its components. 12. Pregnancy, potential pregnancy, or breastfeeding. 13. Currently participating in other clinical trials during the past 3 months. 14. Those who are judged by researchers to have poor compliance or are not suitable for participating in this study for any other reason.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dongzhimen Hospital, Beijing University of Chinese Medicine Richmond British Columbia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07163702 on ClinicalTrials.gov ↗ ← All trials in Canada