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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Infarction; Clinical Trial; Chinese Herbal Medicine; Lipid Metabolism Disorder; Endothelial Injury
• Intervention / Treatment: Other: Taohong Tongluo Xiaoban Prescription; Other: Fundamental medical treatment

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The CT/MRI examination findings were consistent with the diagnosis of Western cerebral infarction, aligning with the TCM apoplexy diagnosis. Primary stroke occurred 35±5 days ago.
2. The National Institutes of Health Stroke Scale (NIHSS) evaluates a range of scores from 4 to 24.
3. Coronary atherosclerotic heart disease is confirmed through coronary CT angiography. Carotid artery ultrasonography is employed to ascertain the presence or absence of plaque formation, with stable plaques exhibiting predominantly high and uneven echogenicity, while unstable plaques displayed low echo or irregular hypoechoic regions.
4. Age range: ≥35 years to ≤80 years.
5. First onset requires; patients with previous diseases and no sequelae such as limb paralysis should not affect the NIHSS score, and the modified Rankin scale (mRS) score should be ≤1 point.
6. Patient informed consent must be obtained.

7. The criteria for the syndrome of phlegm and blood stasis are as follows: Main syndrome: hemiplegia, mouth and eyes skew, speech retarding or silent, sensation diminished or disappeared; Secondary syndrome: excessive sputum, fat tongue with teeth marks on the side, dark red tongue, sublingual vein blue or tortuous, tongue spots, white or thick greasy fur, pulse slippery.

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Exclusion Criteria:

1. subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cerebral cysticercosis, intracerebral schistosomiasis, encephalitis, meningitis, hydrocephalus, and sequelae of brain trauma; Nonatherosclerotic thrombotic cerebral infarction (e.g., cardiogenic embolism, hypercoagulability disorders, endovascular shedding and arteritis);
2. onset occurring within a range of 30 to 40 days；
3. The patient presents with limb motor dysfunction, emotional disorder, cognitive impairment, or speech impairment resulting from pre-existing conditions (e.g., surgery, trauma, or congenital disability) prior to the onset of cerebrovascular accident.
4. Patients with severe cardiac disease, heart failure, liver or kidney failure, malignant tumors, gastrointestinal bleeding, severe infections, or uncontrolled diabetes are excluded from the study.
5. Individuals currently participating in other clinical trials are not eligible for inclusion.
6. Exclusion criteria include patients with mental illness, multiple body ulcers or joint contractures.
7. Non-compliance with treatment by patients and their families is considered an exclusion criterion.
8. Inability to comprehend the content of informed consent and inability to provide a signature on the informed consent form are also grounds for exclusion.

9. . Pregnant and lactating women are excluded from participation.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Fundamental medical treatment+Taohong Tongluo Xiaoban Prescription Incorporating the 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: 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.
Active Comparator: control group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yan Zhu

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Wounds and Injuries; Cerebral Infarction; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: Th Tl Xb PrescriptionlY2024007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No