Clinical trial NCT04472754: The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study
Official title: The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Protein; Disease
Keywords: ischemic stroke
phlegm dampness syndrome
traditional Chinese medicine
proteomic
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guangzhou Cadre Health Management Center
First posted: 2020-07-15
Enrollment: 400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population are people who diagnosed as ischemic stroke at Guangdong Provincial Hospital of Chinese Medicine The healthy volunteers are definted as people who have no history of cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.)

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of ischemic stroke
2. Aged 35-80-year-old.
3. Agree to participate in clinical research and sign informed consent.

Exclusion Criteria:

1. Clinical diagnosis of cerebral hemorrhage;
2. With severe infection, severe renal dysfunction, and tumor;
3. Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections;
4. Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis;
5. Pregnant women or lactating mothers

Primary outcomes:
measure: Differentially expressed proteins of urine and saliva
timeFrame: 1 day
Secondary outcomes:
measure: NIHSS scoes
timeFrame: 1 day
measure: modified Rankin Scale (mRS) score
timeFrame: 1 day
measure: BI index
timeFrame: 1 day
Other outcomes:
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