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Screening Protein Markers in Patients With Rheumatoid Arthritis and Hot-dampness and Blood Stasis Syndrome

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ClinicalTrials.gov Identifier: NCT02408094
Recruitment Status : Unknown
Verified April 2017 by Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease
Arthritis, Rheumatoid

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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 Start Date : May 2015
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. serum and saliva protein markers [ Time Frame: six hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with rheunmtoid arthritis and "heat-dampness and blood stasis" syndrome
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408094


Contacts
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Contact: Jiao Juan, Doctor 01088001030 jiao.juan@hotmail.com

Locations
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China, Beijing
Guang'anmen Hospital Recruiting
Beijing, Beijing, China
Contact: Jiao Juan, Doctor    01088001030    jiao.juan@hotmail.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
National Natural Science Foundation of China
Investigators
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Principal Investigator: Jiao Juan, Doctor Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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Responsible Party: Juan Jiao, Attending physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02408094     History of Changes
Other Study ID Numbers: 81403364
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Rheumatoid Arthritis
Heat-dampness and blood stasis syndrome
Protein markers
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Blind Loop Syndrome
Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases