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

NCT ID: NCT04472754

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-06-30

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.

Conditions

Protein; Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A(healthy control group)

patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful;

No interventions assigned to this group

B

Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution

No interventions assigned to this group

C

patients with ischemic stroke diagnosed with phlegm dampness syndrome

No interventions assigned to this group

D

patients with ischemic stroke diagnosed as non-phlegm dampness syndrome

No interventions assigned to this group

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Cadre Health Management Center

UNKNOWN

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

8388

Identifier Type: -

Identifier Source: org_study_id