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NCT02564913 Clinical Trial

Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02564913
Other study ID # 111106
Secondary ID
Status Completed
Phase N/A
First received September 29, 2015
Last updated September 29, 2015
Start date December 2011
Est. completion date November 2014

Study information
Verified date September 2015
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• clinical evaluation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Changhua Christian Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary tongue diagnosis 1 year No
Primary heart rate variability 1 year No
Primary nailfold videocapillaroscopy 1 year No
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