Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke

NCT07163702 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025DZMEC-251-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; Xinglou Chengqi granules; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The change of NIHSS score from baseline to day 14.

  The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups.

  Baseline and Day 14.

Secondary Outcomes (5)

• The proportions of patients with mRS ≤ 2 or mRS ≤ 1.

  Day 30, Day 60 and Day 90.

• The change of NIHSS score

  Day 7, day 30, day 60, day 90.

• The proportion of patients with Barthel Index score ≥ 95 or ≥ 75.

  day 7, day 14, day 30, day 60, day 90.

• The change of EQ-5D score.

  day 7, day 14, day 30, day 60, day 90.

• The incidence of new cardiovascular events.

  day 7, day 14, day 30, day 60, day 90.

Study Arms (2)

High-dose group

EXPERIMENTAL

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

Drug: High-dose Xinglou Chengqi granules

Low-dose group

ACTIVE COMPARATOR

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

Drug: Low-dose Xinglou Chengqi granules and placebo

Interventions

High-dose Xinglou Chengqi granules DRUG

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

Also known as: Guidelines-based standard care

High-dose group

Low-dose Xinglou Chengqi granules and placebo DRUG

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

Also known as: Guidelines-based standard care

Low-dose group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients diagnosed with acute ischemic stroke.
• Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome.
• Acute ischemic stroke within 7 days after onset.
• ≤ NIHSS \<20.
• Aged 18-70 years, male or female.
• The patient or representative has signed informed consent.

You may not qualify if:

• Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
• NIHSS Ⅰa ≥2.
• Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
• Received or planned thrombolysis or endovascular therapy after onset.
• 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)
• With cancers or uncontrolled diabetes.
• The expected survival time is less than 3 months.
• Patients who have used other traditional Chinese medicine for treating acute ischemic stroke since stroke onset.
• Patients with severe mental disorders, dementia, or other comorbid diseases that may affect neurological function examination.
• With a history of alcohol or drug abuse or drug dependence.
• Those known to be allergic to the investigated drug or its components.
• Pregnancy, potential pregnancy, or breastfeeding.
• Currently participating in other clinical trials during the past 3 months.
• Those who are judged by researchers to have poor compliance or are not suitable for participating in this study for any other reason.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Richmond, British Columbia, V7E 6J1, Canada

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xinxing Lai, M.D.

CONTACT

+8615901111280; new-star@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

CA (1)