Acute Ischemic StrokeNCT06883110
Angong Niuhuang Pills With Different Bovine Bezoar Formulation Sources in the Treatment of AIS
A study testing Z11020076 and Z20063878 in people with Acute Ischemic Stroke, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Z11020076 and Z20063878
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hemorrhagic or mixed stroke.
- Severe cardiac, hepatic, or renal dysfunction or malignancy.
- 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.
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- 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.
- Concurrent or recent (within 90 days) participation in other clinical trials.
- 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.
- Significant hearing/visual impairment, language barriers, claustrophobia, or other conditions interfering with neuropsychological assessments or MRI.
- Any other unspecified reasons deemed by the investigator to disqualify participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Ke Shang, PhD, 8602783663477, kay_sang@hust.edu.cn
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Z11020076, Z20063878
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z11020076Drug
Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
Z20063878Drug
Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Z11020076 group | Experimental | In addition to receiving standard therapy for acute ischemic stroke (AIS), participants were administered Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
Note: The AIS standard therapy strictly adhered to first-line treatments recommended by the Chinese guidelines for acute cerebral infarction management. Receives: Drug: Z11020076 |
| Z20063878 group | Experimental | In addition to receiving standard therapy for acute ischemic stroke (AIS), participants were administered Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days.
Note: The AIS standard therapy strictly adhered to first-line treatments recommended by the Chinese guidelines for acute cerebral infarction management Receives: Drug: Z20063878 |
| blank control group | No intervention | Participants would receive AIS standard therapy strictly adhered to first-line treatments recommended by the Chinese guidelines for acute cerebral infarction management |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Score
Measured: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)
NIHSS
Measured: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)
1a score in NIHSS
Measured: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Sep 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daishi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883110
- Sponsor's protocol ID
- AgNhWinAIS
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06883110
- Acronym / sponsor ID
- AgNhWinAIS
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Z11020076 group | Experimental | Drug: Z11020076In addition to receiving standard therapy for acute ischemic stroke (AIS), participants were administered Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days. Note: The AIS standard therapy strictly adhered to first-line treatments recommended by the Chinese guidelines for acute cerebral infarction management. |
| Z20063878 group | Experimental | Drug: Z20063878In addition to receiving standard therapy for acute ischemic stroke (AIS), participants were administered Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days. Note: The AIS standard therapy strictly adhered to first-line treatments recommended by the Chinese guidelines for acute cerebral infarction management |
| blank control group | No intervention | –Participants would receive AIS standard therapy strictly adhered to first-line treatments recommended by the Chinese guidelines for acute cerebral infarction management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Hemorrhagic or mixed stroke.
- Severe cardiac, hepatic, or renal dysfunction or malignancy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z11020076Beijing Tongrentang Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days. | Drug | Z11020076 group |
| Z20063878Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. Angong Niuhuang Pills (3g once daily as a single dose) for 7 consecutive days. | Drug | Z20063878 group |
Primary outcome
modified 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z11020076 and Z20063878 in people with Acute Ischemic Stroke, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Score (time frame: Day 1, Day 7 (±1), Day 14 (±3), and Day 84 (±5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.