Status:
NOT_YET_RECRUITING
Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke
Lead Sponsor:
Dongzhimen Hospital, Beijing
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07163702
Start Date
October 1 2025
End Date
September 30 2026
Last Update
September 9 2025
Active Locations (1)
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1
Dongzhimen Hospital, Beijing University of Chinese Medicine
Richmond, British Columbia, Canada, V7E 6J1