- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408094
Screening Protein Markers in Patients With Rheumatoid Arthritis and Hot-dampness and Blood Stasis Syndrome
April 22, 2017 updated by: Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Screening Sensitive Protein Markers and Exploring Application in Syndrome Diagnosis of Hot-dampness and Blood Stasis Syndrome in Patients With Rheumatoid Arthritis
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiao Juan, Doctor
- Phone Number: 01088001030
- Email: jiao.juan@hotmail.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China
- Recruiting
- Guang'anmen hospital
-
Contact:
- Jiao Juan, Doctor
- Phone Number: 01088001030
- Email: jiao.juan@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with rheunmtoid arthritis and "heat-dampness and blood stasis" syndrome
Description
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:
- Subjects have other serious diseases, such as liver and kidney disease, cerebral-cardio vascular diseases.
- Subjects, who belong to "non-heat-dampness and blood stasis" syndrome, have double syndrome of heat or dampness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum and saliva protein markers
Time Frame: six hours
|
six hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jiao Juan, Doctor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
March 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
April 2, 2015
First Posted (Estimate)
April 3, 2015
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 22, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Disease
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Intestinal Diseases
- Malabsorption Syndromes
- Syndrome
- Arthritis
- Arthritis, Rheumatoid
- Blind Loop Syndrome
Other Study ID Numbers
- 81403364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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