NCT06549582

Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients

Effect of Taohong Tongluo Xiaoban Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients：a Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Yan Zhu · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, randomized control trial. It is planning to include 160 cerebral infarction patients which will be randomized in a 1﹕1 fashion to receive Chinese herbal medicines combined basic medicine treatment, or to receive standard basic medicine treatment within 3 months after inclusion. Follow-up will be performed after the treatment for 3 months to evaluate the incidence and disability rates of limb impairment, language impairment, cognitive impairment, and emotional disorders. The primary outcome is modified Rankin Scale Score, which is measured by the overall distribution from 0 (no symptoms) to 6 (death). The secondary outcome include the Evaluation of Neurological Function Deficit score (National Institute of Health stroke scale scoring) and carotid atherosclerotic plaque score (Crouse scoring system for neck carotid atherosclerotic plaque scoring). Additional outcomes include laboratory indicator to analysis the reprogramming of lipid metabolism and endothelial Injury, Chinese medicine symptom and sign scoring system and biological indicators. The investigators will perform the intention-to-treat analysis for withdrawal and missing data, and estimate the health economic value.

Conditions

• Cerebral Infarction
• Chinese Herbal Medicine
• Clinical Trial
• Lipid Metabolism Disorder
• Endothelial Injury

Interventions

Type	Name	Description
OTHER	Taohong Tongluo Xiaoban Prescription	Chinese herbal medicine "Taohong Tongluo Xiaoban prescription", which includes Pinelliae Rhizoma, Poria, Bambusae caulis in taenias, Aurantii Fructus Immaturus, Arisaema cum bile, Acori Tatarinowii Rhizoma, Persicae Semen, Carthami Flos, Chuanxiong Rhizoma and Paeoniae Radix Rubra as a once - daily dosage with one administration per dose
OTHER	Fundamental medical treatment	The specific methods were developed in accordance with the 2010 Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack. It primarily involves managing risk factors such as hypertension, diabetes, abnormal lipid metabolism, etc., and implementing antithrombotic therapy including antiplatelet agents (aspirin, clopidogrel, dipyridamole, dipyridamole + aspirin, clopidogrel + aspirin, silostazole, triflurosal, etc). For the management of post-stroke mood disorders, cognitive impairments, and spastic paralysis, pharmacological interventions encompass oral administration of anxiolytic or antidepressant agents, anti-dementia medications, as well as muscle relaxants.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-08-12
• Last updated: 2024-08-14