Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS
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
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Z11020076
Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
Z20063878
Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.