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Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis

This study has been completed.
Study NCT00071149.   Last updated on August 17, 2006.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis
Official Title  Consistency of Traditional Chinese Medicine Rheumatoid Arthritis Diagnosis and Herbal Prescriptions
Brief Summary

Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently.

Detailed Description

TCM is one of the oldest and most widely-used indigenous medical systems in the world. It is difficult to effectively practice or evaluate TCM outside of its core framework, which includes a diagnostic system that is more conceptual and less technologically driven than that of conventional medicine. TCM diagnosis relies entirely on clinical symptoms and signs that are discerned by the practitioner. The establishment of diagnostic and prescriptive consistency is crucial for efficacy studies involving individualized treatments within the TCM framework. This study will examine the consistency of TCM diagnoses and herbal prescriptions under controlled conditions.

Rheumatoid arthritis (RA) patients will be individually evaluated by three TCM practitioners; the diagnostic and prescriptive behaviors of the practitioners will be recorded and analyzed to determine: 1) the extent to which two or more TCM practitioners assign comparable TCM diagnoses to the same RA patients; 2) the extent to which two or more TCM practitioners prescribe comparable herbal formulas to the same RA patients; and 3) the extent to which TCM diagnoses are related to conventional clinical assessments and biomedical tests of RA. Variables that cause inconsistency will be identified and analyzed.

Study Phase
Study Type  Observational
Study Design  Natural History, Cross-Sectional, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Rheumatoid Arthritis
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  120
Start Date  November 2001
Completion Date April 2004
Eligibility Criteria 

Inclusion Criteria

  • Rheumatoid arthritis
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00071149
Organization ID R21 AT000590-01
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Grant G Zhang, PhD     University of Maryland    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date July 2006
First Received Date  October 14, 2003
Last Updated Date August 17, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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