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

Status

Completed

Conditions

Intervention / Treatment

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
Other: clinical evaluation
DM group
pre-DM group
Other: clinical evaluation

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

Changhua Christian Hospital

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

Keywords

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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