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

• Conditions: Protein; Disease

• Registration Number: NCT04472754
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-07-11
• Last Update Submitted: 2020-07-11
• Study First Posted: 2020-07-15
• Last Update Posted: 2020-07-15
• Study Start: 2020-08-01
• Primary Completion: 2020-12-20
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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