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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02408094
Other study ID # 81403364
Secondary ID
Status Recruiting
Phase N/A
First received March 31, 2015
Last updated April 22, 2017
Start date May 2015
Est. completion date December 2017

Study information

Verified date April 2017
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Jiao Juan, Doctor
Phone 01088001030
Email jiao.juan@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China Guang'anmen Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum and saliva protein markers six hours
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