Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI

NCT ID: NCT06874140

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Chuanhong Zhongfeng capsule

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

Group Type EXPERIMENTAL

Chuanhong Zhongfeng capsule

Intervention Type DRUG

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

control

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

Group Type ACTIVE_COMPARATOR

Chuanhong Zhongfeng capsule

Intervention Type DRUG

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

Interventions

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Chuanhong Zhongfeng capsule

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

Intervention Type DRUG

Eligibility Criteria

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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. -
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yingyue Ding

OTHER

Sponsor Role lead

Responsible Party

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Yingyue Ding

Attending physician of the Department of Encephalopathy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Changchun, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40517620 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2022JC046

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CCZYFYKYLL2023

Identifier Type: -

Identifier Source: org_study_id

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