NCT06883110

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Z11020076	Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
DRUG	Z20063878	Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-03-19
• Last updated: 2026-01-12

Locations

1 site across 1 country: China