Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS

Inclusion Criteria:

• Participants or their legal guardians must be capable of understanding the study'spurpose and risks and provide informed consent.

• Eligible subjects are aged 18-80 years (inclusive) at the time of consent,regardless of gender.

• All individuals of childbearing potential and male participants must use effectivecontraception during the study and for at least 6 months after the last dose of theinvestigational treatment. Additionally, participants must refrain from donatingsperm or eggs during the study and for at least 6 months post-treatment.

• Inclusion criteria included: confirmed diagnosis of acute ischemic stroke (AIS) withsymptom onset ≤48 hours, NIHSS score of 4-20 (with NIHSS category 1a [level ofconsciousness] ≥1), and exclusion of intracranial hemorrhage confirmed by imaging (CT or MRI).

• Participants must meet traditional Chinese medicine (TCM) diagnostic criteria forstroke (per the Diagnostic and Efficacy Evaluation Standards for Stroke in TCMissued by the State Administration of Traditional Chinese Medicine),including:Primary symptoms: Hemiplegia, altered consciousness, slurred speech oraphasia, sensory disturbance, facial deviation.Secondary symptoms: Headache,dizziness, pupillary abnormalities, dysphagia, gaze deviation, ataxia.Diagnosisrequires ≥2 primary symptoms or 1 primary symptom plus ≥2 secondary symptoms.Written informed consent must be obtained.

Exclusion Criteria:

• Hemorrhagic or mixed stroke.

• Severe cardiac, hepatic, or renal dysfunction or malignancy.

• Prior stroke resulting in a baseline modified Rankin Scale (mRS) score >3.

• Use of medications judged by the investigator to significantly affect gut microbiotaor immune function (e.g., antibiotics, immunosuppressants) during the window period (3 days before baseline to 14±3 days post-treatment).

• Allergy to the investigational product or its components.

• Prior participation in this study.

• Blood donation (≥1 unit) within 90 days, plasma donation within 1 week, or plateletdonation within 6 weeks before screening.

• Pregnancy, lactation, or plans for pregnancy/breastfeeding during the study orwithin 30 days post-treatment.

• Concurrent or recent (within 90 days) participation in other clinical trials.

• Clinically significant suicidal ideation or behavior within the past 12 months perColumbia-Suicide Severity Rating Scale (C-SSRS).

• Inability or unwillingness to comply with protocol requirements.

• Significant hearing/visual impairment, language barriers, claustrophobia, or otherconditions interfering with neuropsychological assessments or MRI.

• Any other unspecified reasons deemed by the investigator to disqualifyparticipation.