Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI

NCT06874140 | Completed Phase 1 DMC

• 2 other identifiers: CCZYFYKYLL20232022JC046
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Chuanhong Zhongfeng capsule

EXPERIMENTAL

Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule

Drug: Chuanhong Zhongfeng capsule

control

ACTIVE COMPARATOR

Basic treatment (refer to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)

Drug: Chuanhong Zhongfeng capsule

Interventions

Chuanhong Zhongfeng capsule DRUG

Basic treatment (refer to China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018) + Chuanhong Zhongfeng capsule

Chuanhong Zhongfeng capsule; control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≤ NIHSS score \<15.
• Age 40-80 years old. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Yingyue Ding: lead

Study Sites (1)

Unknown Facility

Changchun, China

Location

Related Publications (1)

• 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.

  PMID: 40517620 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician of the Department of Encephalopathy

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CN (1)