Rheumatoid ArthritisNCT00071149
Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Apr 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consistency of Traditional Chinese Medicine Rheumatoid Arthritis Diagnosis and Herbal Prescriptions
Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, TCM, Diagnosis, Traditional Chinese Medicine, Complementary Therapies
- Medical subject headings
- Arthritis, Rheumatoid, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2003 (estimated)
- Study startNov 2001
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Grant G Zhang, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071149
- Sponsor's protocol ID
- R21AT000590-01
- Status last verified
- Jul 2006
- First submitted
- 14 Oct 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency of Traditional Chinese Medicine Rheumatoid Arthritis Diagnosis and Herbal Prescriptions
- ClinicalTrials.gov ID
- NCT00071149
- Acronym / sponsor ID
- R21AT000590-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, TCM, Diagnosis, Traditional Chinese Medicine, Complementary Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2001
- Study completion
- Apr 2004
- First posted
- 15 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant G Zhang, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.