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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGmodified Rankin Score
Time frame: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)
NIHSS
Time frame: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)
1a score in NIHSS
Time frame: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)
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