The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study

Study Overview
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Brief Summary
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This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.

Detailed Description
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Stroke is the disease with the highest mortality and disability in China, and the annual incidence of ischemic stroke is the highest. Atherosclerosis is the main cause of ischemic stroke. According to the theory of traditional Chinese medicine, the disease is closely related to the physical constitution of the individual. The main body constitution of the population in Lingnan area is phlegm dampness syndrome;Previous large cross-sectional studies have found that 65.3% of patients with ischemic stroke in Lingnan area have phlegm dampness syndrome. However, there is currently no biological evidence related to phlegm-dampness syndrome and ischemic stroke.In recent years, proteomics research technology has developed vigorously. The research samples have developed from blood obtained from minimally invasive to urine and saliva obtained non-invasively. Studies have found that urine proteins associated with AS include type I, type III collagen, 8-isoprostaglandin F2α, and saliva proteins include IL-1β, IL-6, TNF-α, and PGE2.Therefore, this research is dedicated to exploring the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.

Official Title
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The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study

Conditions
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Protein; Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ischemic stroke Aged 35-80-year-old. Agree to participate in clinical research and sign informed consent. Exclusion Criteria: Clinical diagnosis of cerebral hemorrhage; With severe infection, severe renal dysfunction, and tumor; Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections; Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis; Pregnant women or lactating mothers

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A(healthy control group)<br>patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful; | |
| B<br>Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution | |
| C<br>patients with ischemic stroke diagnosed with phlegm dampness syndrome | |
| D<br>patients with ischemic stroke diagnosed as non-phlegm dampness syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentially expressed proteins of urine and saliva | Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS scoes | NIHSS scoring scale for neurological impairment assessment | 1 day | 
| modified Rankin Scale (mRS) score | mRS score for the degree of dependence | 1 day | 
| BI index | BI index for living ability assessment | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, phlegm dampness syndrome, traditional Chinese medicine, proteomic