Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke
NCT ID: NCT07163702
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-10-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High-dose group
16 g of Xinglou Chengqi granules will be given to participants in the high-dose group.
High-dose Xinglou Chengqi granules
Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Low-dose group
8 g of Xinglou Chengqi granules and 8 g of placebo will be given to participants in the low-dose group.
Low-dose Xinglou Chengqi granules and placebo
Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Dongzhimen Hospital, Beijing
OTHER
Responsible Party
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Ying Gao
Professor
Locations
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Dongzhimen Hospital, Beijing University of Chinese Medicine
Richmond, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025DZMEC-251-02
Identifier Type: -
Identifier Source: org_study_id
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