Angong Niuhuang pills with different bovine bezoar sources for acute ischemic stroke
A Single-Center, Open-Label, Non-Inferiority Clinical Study of Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of Acute Ischemic Stroke
This will try two commercially made Angong Niuhuang pill formulations to see if they help adults with recent acute ischemic stroke recover better and reduce inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06883110 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label, controlled trial enrolling 100 participants into two active formulation groups (40 each) and a 20-person control group with 84 days of follow-up. Participants are adults aged 18–80 with confirmed acute ischemic stroke within 48 hours and NIHSS scores of 4–20, and must meet specified traditional Chinese medicine diagnostic criteria. The primary aim is to compare the efficacy and safety of Angong Niuhuang pills from two manufacturers on clinical functional outcomes and prognosis, while secondary analyses will measure changes in gut microbiota, peripheral immune function, and inflammatory markers. Clinical data, imaging, and biospecimens will be collected prospectively to link clinical effects with biological measures.
Who should consider this trial
Good fit: Adults aged 18–80 with confirmed acute ischemic stroke onset within 48 hours, NIHSS score between 4 and 20, no intracranial hemorrhage on imaging, and meeting the trial's TCM diagnostic criteria are eligible.
Not a fit: Patients with hemorrhagic stroke, symptom onset beyond 48 hours, NIHSS scores outside the 4–20 range, or who do not meet the study's TCM criteria are unlikely to benefit from participating in this protocol.
Why it matters
Potential benefit: If successful, one or both formulations could provide a safe adjunctive therapy that improves functional recovery and reduces inflammation after acute ischemic stroke.
How similar studies have performed: Some small and heterogeneous trials of Angong Niuhuang and related traditional Chinese medicines have reported improved neurological outcomes and reduced inflammatory markers, but high-quality randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants or their legal guardians must be capable of understanding the study's purpose 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 effective contraception during the study and for at least 6 months after the last dose of the investigational treatment. Additionally, participants must refrain from donating sperm or eggs during the study and for at least 6 months post-treatment. * Inclusion criteria included: confirmed diagnosis of acute ischemic stroke (AIS) with symptom onset ≤48 hours, NIHSS score of 4-20 (with NIHSS category 1a \[level of consciousness\] ≥1), and exclusion of intracranial hemorrhage confirmed by imaging (CT or MRI). * Participants must meet traditional Chinese medicine (TCM) diagnostic criteria for stroke (per the Diagnostic and Efficacy Evaluation Standards for Stroke in TCM issued by the State Administration of Traditional Chinese Medicine), including:Primary symptoms: Hemiplegia, altered consciousness, slurred speech or aphasia, sensory disturbance, facial deviation.Secondary symptoms: Headache, dizziness, pupillary abnormalities, dysphagia, gaze deviation, ataxia.Diagnosis requires ≥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 microbiota or 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 platelet donation within 6 weeks before screening. * Pregnancy, lactation, or plans for pregnancy/breastfeeding during the study or within 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 per Columbia-Suicide Severity Rating Scale (C-SSRS). * Inability or unwillingness to comply with protocol requirements. * Significant hearing/visual impairment, language barriers, claustrophobia, or other conditions interfering with neuropsychological assessments or MRI. * Any other unspecified reasons deemed by the investigator to disqualify participation.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.