Compares two versions of Angong Niuhuang Pills in acute ischemic stroke
Tests two versions of Angong Niuhuang Pills in people with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS
Key facts
- Where
- Wuhan, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 who have had an acute ischemic stroke with symptoms starting 48 hours ago or less. It compares two makers of Angong Niuhuang Pills.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with symptom onset of 48 hours or less, NIHSS score of 4-20 (with NIHSS item 1a, level of consciousness, of 1 or more). A brain scan (CT or MRI) must rule out bleeding in the brain. Must also meet traditional Chinese medicine stroke diagnosis criteria.
- Earlier treatment
- Cannot have used drugs that strongly affect gut bacteria or the immune system (for example antibiotics or immunosuppressants) from 3 days before the start until 14±3 days after treatment.
Main reasons for not taking part
- Bleeding stroke or mixed stroke
- Severe heart, liver or kidney problems, or cancer
- Earlier stroke leaving a modified Rankin Scale score above 3
- Allergy to the study drug or its parts
- Pregnancy, breastfeeding, or plans for either during the study or within 30 days after treatment
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06883110, who can take part
Where in China
- Tongji HospitalWuhan, ChinaContact: Ke Shang, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tongji Hospital
- Trial code
- NCT06883110
- Record updated
- 12 January 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants or their legal guardians must be capable of understanding the study's purpose and risks and provide informed consent; Eligible subjects are aged 18-80 years (inclusive) at the time of consent, regardless of gender; All individuals of childbearing potential and male participants must use effective contraception during the study and for at least 6 months after the last dose of the investigational treatment. Additionally, participants must refrain from donating sperm or eggs during the study and for at least 6 months post-treatment; Inclusion criteria included: confirmed diagnosis of acute ischemic stroke (AIS) with symptom onset ≤48 hours, NIHSS score of 4-20 (with NIHSS category 1a [level of consciousness] ≥1), and exclusion of intracranial hemorrhage confirmed by imaging (CT or MRI); Participants must meet traditional Chinese medicine (TCM) diagnostic criteria for stroke (per the Diagnostic and Efficacy Evaluation Standards for Stroke in TCM issued by the State Administration of Traditional Chinese Medicine), including:Primary symptoms: Hemiplegia, altered consciousness, slurred speech or aphasia, sensory disturbance, facial deviation.Secondary symptoms: Headache, dizziness, pupillary abnormalities, dysphagia, gaze deviation, ataxia.Diagnosis requires ≥2 primary symptoms or 1 primary symptom plus ≥2 secondary symptoms. Written informed consent must be obtained.
Exclusion: Prior stroke resulting in a baseline modified Rankin Scale (mRS) score >3; Use of medications judged by the investigator to significantly affect gut microbiota or immune function (e.g., antibiotics, immunosuppressants) during the window period (3 days before baseline to 14±3 days post-treatment); Allergy to the investigational product or its components; Prior participation in this study; Concurrent or recent (within 90 days) participation in other clinical trials; Hemorrhagic or mixed stroke; Severe cardiac, hepatic, or renal dysfunction or malignancy; Significant hearing/visual impairment, language barriers, claustrophobia, or other conditions interfering with neuropsychological assessments or MRI; Blood donation (≥1 unit) within 90 days, plasma donation within 1 week, or platelet donation within 6 weeks before screening; Pregnancy, lactation, or plans for pregnancy/breastfeeding during the study or within 30 days post-treatment; Clinically significant suicidal ideation or behavior within the past 12 months per Columbia-Suicide Severity Rating Scale (C-SSRS); Inability or unwillingness to comply with protocol requirements; Any other unspecified reasons deemed by the investigator to disqualify participation.