Acute Ischemic StrokePhase 1NCT06874140
Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI
A Phase 1 study testing Chuanhong Zhongfeng capsule in people with Acute Ischemic Stroke, run by Yingyue Ding at 1 site in China.
Trial summary
Acute cerebral infarction is characterized by high disability rate and high recurrence rate, which poses a great threat to the life and health of the nation. Proteomics technology is a holistic and comprehensive understanding of disease mechanism, cell metabolism and other processes at the protein level. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Chuanhong Zhongfeng capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for ischemic stroke in the Chinese Guidelines for Diagnosis and Treatment of Ischemic Stroke in the Acute Phase 2018.
- Meet the diagnostic criteria for ischemic stroke in Chinese medicine.
- Within 2 weeks of acute onset of ischemic stroke.
- 4 ≤ NIHSS score <15.
- Age 40-80 years old. -
Who cannot join
- Diagnosis of hemorrhage or other pathological brain disorders based on head CT or MRI;
- Allergic individuals, those who are allergic to the test medication or the associated medicinal flavors or components thereof;
- Age <40 years or >80 years;
- Those with severe liver or kidney function impairment. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers and Potential Mechanisms of Chinese Medicine Compound (Chuanhong Zhongfeng Capsule) in the Treatment of Acute Cerebral Infarction
Acute cerebral infarction is characterized by high disability rate and high recurrence rate, which poses a great threat to the life and health of the nation. Proteomics technology is a holistic and comprehensive understanding of disease mechanism, cell metabolism and other processes at the protein level. The correlation between acute cerebral infarction and proteomics has become a hot spot of clinical and basic research in recent years. Chuanhong Zhongfeng capsule was developed by Ren Jixue, a master of national medicine, and clinical studies have confirmed that it not only promotes the recovery of neurological function in patients with cerebral infarction, reduces the disability rate, but also improves the long-term prognosis, but its mechanism of action and its target are still unclear. In the present study, we applied 4D Label-free proteomics technology and PRM technology to study for the first time the mechanism of action and potential targets of Chuanhong Zhongfeng Capsule in the treatment of acute cerebral infarction, which will provide a direction for the study of traditional Chinese medicine compounding for the prevention and treatment of cerebral infarction.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Chuanhong Zhongfeng capsule
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chuanhong Zhongfeng capsuleDrug
Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule
| Study group | Role | What they receive |
|---|---|---|
| Chuanhong Zhongfeng capsule | Experimental | Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule Receives: Drug: Chuanhong Zhongfeng capsule |
| control | Active comparator | Basic treatment (refer to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018) Receives: Drug: Chuanhong Zhongfeng capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore protein expression levels, post-translational modifications, protein-protein interactions, and obtain protein-level insights into disease mechanisms and disease biomarkers.
The study focused on identifying unique differential proteins in ACI patients treated with CHZF Capsule. Mass spectrometry analysis was performed using 4D label-free proteome quantification technology to identify differential proteins between the groups. Functional enrichment analysis, including GO classification and KEGG pathway analysis, was conducted to determine enrichment trends related to differential proteins. Hierarchical clustering was employed to identify relevant pathways enriched in each group based on P-values from the enrichment analysis. The STRING (v.11.5) protein interactions network database was utilized to obtain differential protein interactions, corresponding target proteins, and major related pathways. PRM was subsequently applied to validate the selected target proteins. Finally, chord diagrams and ROC curves were plotted for visualization and analysis.
Measured: 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yingyue Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingyue Ding, Affiliated Hospital of Changchun University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874140
- Sponsor's protocol ID
- CCZYFYKYLL2023
- Other IDs
- 2022JC046
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ding Y, Yao J, Wang X, Liu L, Niu P, Ma H, Zhang L, Wang X, Yang H, Zhao D, Nan H, Wang Y. Biomarkers and potential mechanisms of Chinese medicine compound (Chuanhong Zhongfeng Capsule) in the treatment of acute cerebral infarction. Phytomedicine. 2025 Sep;145:156955. doi: 10.1016/j.phymed.2025.156955. Epub 2025 Jun 11.
PubMed 40517620
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Potential Mechanisms of Chinese Medicine Compound (Chuanhong Zhongfeng Capsule) in the Treatment of Acute Cerebral Infarction
- ClinicalTrials.gov ID
- NCT06874140
- Acronym / sponsor ID
- CCZYFYKYLL2023
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yingyue DingUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 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.
Acute cerebral infarction is characterized by high disability rate and high recurrence rate, which poses a great threat to the life and health of the nation. Proteomics technology is a holistic and comprehensive understanding of disease mechanism, cell metabolism and other processes at the protein level. The correlation between acute cerebral infarction and proteomics has become a hot spot of clinical and basic research in recent years. Chuanhong Zhongfeng capsule was developed by Ren Jixue, a master of national medicine, and clinical studies have confirmed that it not only promotes the recovery of neurological function in patients with cerebral infarction, reduces the disability rate, but also improves the long-term prognosis, but its mechanism of action and its target are still unclear. In the present study, we applied 4D Label-free proteomics technology and PRM technology to study for the first time the mechanism of action and potential targets of Chuanhong Zhongfeng Capsule in the treatment of acute cerebral infarction, which will provide a direction for the study of traditional Chinese medicine compounding for the prevention and treatment of cerebral infarction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chuanhong Zhongfeng capsule | Experimental | Drug: Chuanhong Zhongfeng capsuleBasic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule |
| control | Active comparator | Drug: Chuanhong Zhongfeng capsuleBasic treatment (refer to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria for ischemic stroke in the Chinese Guidelines for Diagnosis and Treatment of Ischemic Stroke in the Acute Phase 2018.
- Meet the diagnostic criteria for ischemic stroke in Chinese medicine.
- Within 2 weeks of acute onset of ischemic stroke.
- 4 ≤ NIHSS score <15.
- Age 40-80 years old. -
Key exclusion criteria (4 listed)
- Diagnosis of hemorrhage or other pathological brain disorders based on head CT or MRI;
- Allergic individuals, those who are allergic to the test medication or the associated medicinal flavors or components thereof;
- Age <40 years or >80 years;
- Those with severe liver or kidney function impairment. -
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 |
|---|---|---|
| Chuanhong Zhongfeng capsuleBasic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule | Drug | Chuanhong Zhongfeng capsule, control |
Primary outcome
Explore protein expression levels, post-translational modifications, protein-protein interactions, and obtain protein-level insights into disease mechanisms and disease biomarkers.
Time frame: 14 day
The study focused on identifying unique differential proteins in ACI patients treated with CHZF Capsule. Mass spectrometry analysis was performed using 4D label-free proteome quantification technology to identify differential proteins between the groups. Functional enrichment analysis, including GO classification and KEGG pathway analysis, was conducted to determine enrichment trends related to differential proteins. Hierarchical clustering was employed to identify relevant pathways enriched in each group based on P-values from the enrichment analysis. The STRING (v.11.5) protein interactions network database was utilized to obtain differential protein interactions, corresponding target proteins, and major related pathways. PRM was subsequently applied to validate the selected target proteins. Finally, chord diagrams and ROC curves were plotted for visualization and analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 40517620Ding Y, Yao J, Wang X, Liu L, Niu P, Ma H, Zhang L, Wang X, Yang H, Zhao D, Nan H, Wang Y. Biomarkers and potential mechanisms of Chinese medicine compound (Chuanhong Zhongfeng Capsule) in the treatment of acute cerebral infarction. Phytomedicine. 2025 Sep;145:156955. doi: 10.1016/j.phymed.2025.156955. Epub 2025 Jun 11.
- Individual participant dataSharing planned: Yes
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chuanhong Zhongfeng capsule in people with Acute Ischemic Stroke, run by Yingyue Ding 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 4 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: finished, as of the sponsor's last update on 13 Mar 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore protein expression levels, post-translational modifications, protein-protein interactions, and obtain protein-level insights into disease mechanisms and disease biomarkers. (time frame: 14 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874140, which also lists 1 linked publication.
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 13 Mar 2025.