Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI

March 7, 2025 updated by: Yingyue Ding

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Meet the diagnostic criteria for ischemic stroke in the Chinese Guidelines for Diagnosis and Treatment of Ischemic Stroke in the Acute Phase 2018.
  2. Meet the diagnostic criteria for ischemic stroke in Chinese medicine.
  3. Within 2 weeks of acute onset of ischemic stroke.
  4. 4 ≤ NIHSS score <15.
  5. Age 40-80 years old. -

Exclusion Criteria:

  1. Diagnosis of hemorrhage or other pathological brain disorders based on head CT or MRI;
  2. Allergic individuals, those who are allergic to the test medication or the associated medicinal flavors or components thereof;
  3. Age <40 years or >80 years;
  4. Those with severe liver or kidney function impairment. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chuanhong Zhongfeng capsule
Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule
Drug: Chuanhong Zhongfeng capsule
Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule
Active Comparator: control
Basic treatment (refer to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
Drug: Chuanhong Zhongfeng capsule
Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
14 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yingyue Ding

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCZYFYKYLL2023
  • 2022JC046 (Other Grant/Funding Number: Jilin Provincial Health Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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