Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke

NCT ID: NCT07163702

Last Updated: 2025-09-09

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

High-dose Xinglou Chengqi granules

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Low-dose Xinglou Chengqi granules and placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Low-dose Xinglou Chengqi granules and placebo

Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.

Intervention Type DRUG

Other Intervention Names

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Guidelines-based standard care Guidelines-based standard care

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongzhimen Hospital, Beijing University of Chinese Medicine

Richmond, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Xinxing Lai, M.D.

Role: CONTACT

+8615901111280

Facility Contacts

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Xinxing Lai, M.D.

Role: primary

+8615901111280

Other Identifiers

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2025DZMEC-251-02

Identifier Type: -

Identifier Source: org_study_id

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