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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04472754

Enrollment

400

Registered

2020-07-15

Start date

2020-08-01

Completion date

2021-06-30

Last updated

2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein; Disease

Keywords

ischemic stroke, phlegm dampness syndrome, traditional Chinese medicine, proteomic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results