drugset / Trial / NCT06883110

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

NCT06883110 ↗

Recruiting 100 enrolled Tongji Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-01
Primary completion
2026-08-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Z11020076 Unknown 3 g —
Subject Z20063878 Unknown 3 g —

Indications