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

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.

Study Overview

• Status: Unknown
• Conditions: Protein; Disease

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 Type: Observational
• Enrollment (Anticipated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
A(healthy control group); patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful;
B; Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution
C; patients with ischemic stroke diagnosed with phlegm dampness syndrome
D; patients with ischemic stroke diagnosed as non-phlegm dampness syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Guangzhou Cadre Health Management Center

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 20, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: July 11, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: proteomic; ischemic stroke; traditional Chinese medicine; phlegm dampness syndrome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 8388

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No