Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS
Trial Parameters
Brief Summary
This study is a single-center, open-label, controlled clinical trial that prospectively enrolls 100 participants (40 in the Z11020076 group, 40 in the Z20063878 group, and 20 in the blank control group) to collect clinical data, imaging data, and biospecimens over an 84-day follow-up period. The primary objective is to compare the efficacy and safety of Angong Niuhuang Pills from Beijing Tongrentang (Approval No. Z11020076) and Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. (Approval No. Z20063878) in improving clinical functional outcomes and prognosis in acute ischemic stroke (AIS) patients. The secondary objective is to evaluate the interventional effects of Angong Niuhuang Pills with different bovine bezoar formulation sources on gut microbiota diversity and composition, peripheral blood immune function, and inflammatory status in AIS patients.
Eligibility 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