- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02564913
Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients
September 29, 2015 updated by: Po-Chi Hsu, Changhua Christian Hospital
In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis.
The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition.
Diabetes mellitus is a metabolic disorder of hyperglycemia, which lead to damage the kidneys, eyes, nerves, blood vessels, and heart.
Long standing hyperglycemia can also be associated with buccal alteration.
The purpose of this study was to survey on tongue diagnosis and other examinations associated with diabetic mellitus.
Study Overview
Study Type
Observational
Enrollment (Actual)
250
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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The investigators recruited the control group , the pre-DM group, and the DM group.
Description
Inclusion Criteria:
- diabetic patients(ac sugar>126mg/dl or HbA1c>6.5, twice)
- pre-diabetic patients(100mg/dl <ac sugar<126mg/dl, or 5.9<HbA1c<6.5)
- non-diabetic patients(ac sugar<100mg/dl )
Exclusion Criteria:
- acute infectious disease,
- cancer,
- End Stage Renal Disease
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
control group
|
|
DM group
|
|
pre-DM group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tongue diagnosis
Time Frame: 1 year
|
1 year
|
heart rate variability
Time Frame: 1 year
|
1 year
|
nailfold videocapillaroscopy
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 29, 2015
First Submitted That Met QC Criteria
September 29, 2015
First Posted (Estimate)
October 1, 2015
Study Record Updates
Last Update Posted (Estimate)
October 1, 2015
Last Update Submitted That Met QC Criteria
September 29, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 111106
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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