Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients
NCT Number: NCT06549582
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Infarction|Chinese Herbal Medicine|Clinical Trial|Lipid Metabolism Disorder|Endothelial Injury
Interventions: OTHER: Taohong Tongluo Xiaoban Prescription|OTHER: Fundamental medical treatment
Sponsor: Yan Zhu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-12

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.

Primary Outcome Measures: Modified Rankin Scale Score, Higher scores mean a worse outcome,measured by the overall distribution from 0 (no symptoms) to 6 (death)., 0,30days,60days and 90days post-intervention
Secondary Outcome Measures: National Institutes of Health Stroke Scale (NIHSS), Higher scores mean a worse outcome,measured by the overall distribution from 0 (normal) to 42 (severe apoplexy)., 0,30days,60days and 90days post-intervention|Carotid atherosclerotic plaque score, Course scoring system for neck carotid atherosclerotic plaque scoring. Higher scores mean a worse outcome,the minimum value is 0 . The plaque score of the carotid artery on each side was calculated by summing up the maximum thickness (mm) of isolated carotid artery plaques, and the total plaque score of each patient was obtained by adding up the plaque scores from both sides., 0 and 90days post-intervention
Other Outcome Measures: Laboratory indicator, ① Vascular inflammatory mediators: IL-6, IL-10, and TNF-α in the serum and cell supernatant of each group will be quantified using ELISA.

② Reprogramming of lipid metabolism: qRT-PCR will be used to detect metabolic enzymes and transcription factors, including HK,LDH, uPFK-2,PKM,PDK, G6PD, CPT1, ATGL, and HSL.

③ Blood lipid: LDL-C,TC, HDL-C and TG., 0 and 90days post-intervention|Score of symptoms and signs in traditional Chinese medicine, Recovery is defined as a curative effect index ≥90% after treatment; Obvious effect referred to a syndrome efficacy index ≥70% and \<90% after treatment; Progress indicated a syndrome efficacy index ≥30% and \<70% after treatment; Ineffective denoted a syndrome efficacy index \<30% after treatment., 0,30days,60days and 90days post-intervention|biological indicator, ① Demographic characteristics: gender, age, educational attainment, stature, body mass index (BMI), occupational status (at baseline).

② Fundamental physiological indicators: body temperature, cardiac rhythm, respiration rate, arterial pressure, and glycemic level.

③ Previous medical history: the presence of blood pressure, blood glucose, and blood lipid abnormalities, as well as a family history of related diseases., 0,30days,60days and 90days post-intervention