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)
The change of NIHSS score from baseline to day 14. — 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.
Trial sites (1)
Facility
City
Region
Status
Dongzhimen Hospital, Beijing University of Chinese Medicine
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.
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