Clinical trial NCT02408094: Screening Protein Markers in Patients With Rheumatoid Arthritis and Hot-dampness and Blood Stasis Syndrome
Official title: Screening Sensitive Protein Markers and Exploring Application in Syndrome Diagnosis of Hot-dampness and Blood Stasis Syndrome in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Heat-dampness and blood stasis syndrome
Protein markers
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2015-04-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheunmtoid arthritis and "heat-dampness and blood stasis" syndrome

Brief summary: The purpose of this study is to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.

Detailed description: RA is one of the main disabling diseases in nowadays, which is an autoimmune disease with complex networks mechanism involving multiple signaling pathways and existing cross path. The investigators consider that the "heat-dampness and blood stasis" syndrome is the main syndrome and major pathogenesis for active RA, which on the base of the theory of traditional Chinese medicine and a large quantity of clinical practice, and also examined by mechanism experiments. But the material basis of this syndrome is remained unclear, lack of high specific objective basis to ensure the syndrome differentiation consistency accurately in clinical practice. Proteomic techniques study cells or the body by all the protein expression and function, thus has the potential efficient for decoding syndrome biological basis. Proteomic techniques are the most effective way to reveal the essence of TCM syndrome. The investigators will use proteomic technology to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA. With strong clinical applicability, this will reveal the scientific connotation of this syndrome, preliminarily guide the syndrome differentiation.

Eligibility criteria: Inclusion Criteria:

* Subjects are made or confirmed diagnosis according to the American College of Rheumatology criterion and "heat-dampness and blood stasis" syndrome according to Traditional Chinese Medicine.

Exclusion Criteria:

1. Subjects have other serious diseases, such as liver and kidney disease, cerebral-cardio vascular diseases.
2. Subjects, who belong to "non-heat-dampness and blood stasis" syndrome, have double syndrome of heat or dampness.

Primary outcomes:
measure: serum and saliva protein markers
timeFrame: six hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiao Juan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: