Randomized controlled trial of Tinospora crispa for additional therapy in patients with type 2 diabetes mellitus.

A randomized double blind placebo controlled trial was conducted to determine the efficacy of Tinospora crispa as additional treatment in patients with type 2 diabetes mellitus who did not respond to oral hypoglycemic drugs and refused insulin injection. Twenty patients were allocated to receive Tinospora crispa powder in capsule form at a dosage of 1 gram thrice daily for 6 months. Twenty patients received a placebo. The main outcomes were changes in fasting plasma glucose, glycosylated hemoglobin and insulin levels. The baseline characteristics of the patients in both groups were not significantly different. There were no significant changes in fasting plasma glucose, glycosylated hemoglobin and insulin levels among the patients within the group and between groups. Two patients who received Tinospora crispa showed marked elevation of liver enzymes that returned to normal after discontinuing Tinospora crispa. Moreover, patients in the Tinospora crispa group had significant weight reduction and cholesterol elevation while taking Tinospora crispa. It is concluded that there is no evidence to support the use of Tinospora crispa 3 grams a day for additional therapy in patients with type 2 diabetes mellitus who did not respond to oral hypoglycemic drugs. The patients receiving Tinospora crispa may have an increased risk of hepatic dysfunction.