CompletedInterventionalPhase 4Updated Dec 11, 2008
Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms | NCT01844050 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 12, 2019
Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
ClinicalTrials.gov ID
NCT01844050
Lead Sponsor
Shanghai University of Traditional Chinese MedicineOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
120Actual
Last Update Posted
Jun 12, 2019Actual
Start Date
Sep 2008
Primary Completion Date
Sep 2009Actual
Completion Date
Oct 2009Actual
Brief Summary
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.
Type 2 Diabetes Mellitus
Chinese herbal medicine
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l<2h PG<16mmol/l
Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
Subject is willing to participate and capable of giving informed consent.
Exclusion Criteria:
Those patients used any drugs for treatment of diabetes within one month.
Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
Women who were pregnant, lactating or planned pregnant.
Allergic constitution and has a history of drug allergy.
Combined with severe acute or chronic infections.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
No central contacts
There are no central contacts for this study.
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality 201108, China
Lead Sponsor
Shanghai University of Traditional Chinese MedicineOTHER