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

Protein; Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04472754
• Other study ID #: 8388
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Protein; Disease
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Guangzhou Cadre Health Management Center

Outcome

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