Actively Recruiting
Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS
Led by Tongji Hospital · Updated on 2026-01-12
100
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their legal guardians must understand the study and provide informed consent.
- Age between 18 and 80 years inclusive.
- Effective contraception required for participants of childbearing potential and males during the study and for 6 months after treatment.
- Confirmed acute ischemic stroke with symptom onset within 48 hours.
- NIH Stroke Scale (NIHSS) score between 4 and 20, with level of consciousness score of at least 1.
- No intracranial hemorrhage confirmed by CT or MRI.
- Meet traditional Chinese medicine criteria for stroke diagnosis, including specific primary and secondary symptoms.
- Written informed consent obtained.
You will not qualify if you...
- Hemorrhagic or mixed stroke.
- Severe heart, liver, or kidney dysfunction or cancer.
- Prior stroke with a modified Rankin Scale score greater than 3.
- Use of medications affecting gut microbiota or immune function during the specified window.
- Allergy to the study medication or its ingredients.
- Previous participation in this study.
- Recent blood, plasma, or platelet donation within set time frames before screening.
- Pregnancy, breastfeeding, or plans for pregnancy during or shortly after the study.
- Participation in other clinical trials within 90 days.
- Significant suicidal thoughts or behavior in the past year.
- Inability or unwillingness to follow study requirements.
- Severe hearing or vision problems, language barriers, claustrophobia, or other issues affecting assessments.
- Other reasons deemed disqualifying by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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