Diabetes mellitus
Conditions
Interventions
Regular treatment plus Kampo formulation goshajinkigan (TJ107) every 3 preprandial for 5 years
Regular treatment
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: volunteers who had type 2 diabetes mellitus and a glycated hemoglobin level of 6.5% or more and who either were between the ages of 40 and 75 years without neither macroalbuminuria nor serum creatinin level of more than 1.3 mg per deciliter nor diabetic retinopathy over pre-proliferative retinopathy.
Exclusion criteria
Exclusion criteria: past macrovascular event including stroke, myocardial infarction, angina pectoris, foot gangrene, atheroscrerotic obstruction and other serious complication, taking other kampo formulation, drug allergy to TJ107, pregnant or lactating women and unwillingness to enter the study. Additional exclusion criteria were a body mass index of ≥30 kg/m2; 2 or more digestive system symptoms (e.g., gastrointestinal weakness, anorexia, nausea, and diarrhea); and 3 or more symptoms or activities indicative of sensitivity to heat, including a preference for dressing lightly, sweating upwards from the neck, a liking for cold water, a flushed face, congestion of the eyeballs, and a tendency towards high body temperatures (not less than 36.7 degrees cercius).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prespecified primary endpoints were the first occurrence of nonfatal myocardial infarction or nonfatal stroke or one or more upstaging of diabetic nephropathy(DN) or retinopathy(DR). | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight, blood pressure, fasting blood glucose, glycated hemoglobin, serum insulin (c-peptide reactivity on insulin user) , total cholesterol, triglycelide, high density lipoprotein, serum creatinin, urea nitrogen and diabetic neuropathy | — |
Countries
Japan
Contacts
Public ContactKenji Watanabe
School of medicine, Keio University centor for Kampo medicine
Outcome results
None listed