Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI

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: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Chuanhong Zhongfeng capsule

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Changchun, China

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

• Sponsor: Yingyue Ding

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID 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