Acute Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, Xinglou Chengqi granules, randomized controlled trial
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 and safety of Xinglou Chengqi Granules for acute ischemic stroke.
Interventions
DRUGHigh-dose Xinglou Chengqi granules
Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
DRUGLow-dose Xinglou Chengqi granules and placebo
Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Sponsors
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportions of patients with mRS ≤ 2 or mRS ≤ 1. | 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. |
| The change of NIHSS score | Day 7, day 30, day 60, day 90. | The change of NIHSS score will be analyzed at days 7, 30, 60, and 90. |
| The proportion of patients with Barthel Index score ≥ 95 or ≥ 75. | 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. |
| The change of EQ-5D score. | 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. |
| The incidence of new cardiovascular events. | 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. |
Countries
Canada
Contacts
Primary ContactXinxing Lai, M.D.
Outcome results
None listed