Clinical trial of antidiabetic traditional medicine formulation (TMF) No. 32

ABSTRACT

Clinical trial to determine the therapeutic efficacy of a traditional antidiabetic drug, TMF-32, was carried out on six Type II NIDDM patients who were admitted to the Traditional Medicine Hospital, Yangon. All patients, 3 males and 3 females, had a fasting blood glucose level of more than 150 mg percent (205.2 + 35.6) and a 2 hour post-prandial blood glucose level of more than 200 mg percent (323.0 + 62.09) and were clinically free from complications of diabetes. The study was a complete cross-over design, using tolbutamide as a control and was conducted under strict diabetic diet wupplying approximately 2500 kcals per day. Hypoglycaemic efficacy calculated from oral glucose tolerance test (OGTT) curves indicated that TMF-32, at doses of 2G and 3G, significantly reduces the blood glucose levels in these patients (p < 0.01 in both doses). The maximum hypoglycaemic effect was seen at approximately 2 hours after dosing and the duration of action lasted only up to 6 hours. Construction of log. dose-response curves showed TMF-32 of having a hypoglycaemic potency of 73 percent of tolbutamide but frequent side effects and cost of drug give rise to contradicting questions on whether it may be useful as a standard traditional antidiabetic drug.