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

NCT04472754 | Unknown DMC

• 1 other identifier: 8388
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Protein; Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• NIHSS scoes

  1 day

• modified Rankin Scale (mRS) score

  1 day

• BI index

  1 day

Study Arms (4)

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

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• Clinical diagnosis of ischemic stroke
• Aged 35-80-year-old.
• Agree to participate in clinical research and sign informed consent.

You may not qualify if:

• Clinical diagnosis of cerebral hemorrhage;
• With severe infection, severe renal dysfunction, and tumor;
• Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections;
• Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis;
• Pregnant women or lactating mothers

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Guangzhou Cadre Health Management Center: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the saliva and urine samples will be stored in the biological resource centre of the our research centre after written informed consent obtained from all subjects who voluntarily participated in this clinical study.

MeSH Terms

Conditions

Disease; Ischemic Stroke

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: July 15, 2020
• Study Start: August 1, 2020
• Primary Completion: December 20, 2020
• Study Completion: June 30, 2021
• Last Updated: July 15, 2020

Record last verified: 2020-05