Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke (EXACT)

Dongzhimen Hospital, Beijing

Status and phase: Not yet enrolling; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: High-dose Xinglou Chengqi granules; Drug: Low-dose Xinglou Chengqi granules and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07163702

2025DZMEC-251-02

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

High-dose group

Experimental group

Description:

16 g of Xinglou Chengqi granules will be given to participants in the high-dose group.

Treatment:

Drug: High-dose Xinglou Chengqi granules

Low-dose group

Active Comparator group

Description:

8 g of Xinglou Chengqi granules and 8 g of placebo will be given to participants in the low-dose group.

Treatment:

Drug: Low-dose Xinglou Chengqi granules and placebo