ong term effect of Japanese Kampo formula gosyajinkigan in diabetic complication; randomized open-labeled trial.
- Conditions
- Diabetes mellitus
- Registration Number
- JPRN-UMIN000010598
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Patients A total of 117 men and women with a median age of 61 years (range, 41 to 76 years) and a median glycated hemoglobin level of 7.5% (range, 6.5 to 12.2%) were randomly assigned to either the TJ107 group or the control group. Approximately 40% of both patient cohorts were women. The key baseline characteristics were similar in the 2 study groups. The mean duration of follow-up was 28 months for the TJ107 group and 15 months for the control group. The trial was stopped when the national funding stopped, although significantly more volunteers were to be included in the trial. Use of Glucose-Lowering Therapy and Other Treatments During the follow-up period, the use of most classes of oral hypoglycemic drugs and of insulin was the same in the 2 groups. In addition, the use of blood pressure-lowering, lipid-modifying, and antiplatelet treatments was similar between the 2 groups during the follow-up period. However, the combined use of several drugs occurred at a much lower frequency than our general experience, so that patients may not have accurately reported medication use in all cases. Effects on Primary Outcomes A total of 43 participants had a microvascular event: 40.2% in the TJ107 group and 39.1% in the control group (P = 0.752, Figure 3). No macrovascular event occurred in either group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1500
Not provided
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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