RESUMO
OBJECTIVES: Andrographis paniculata tablets (AS201-01) have previously been shown to have potent bioactivity as an antimalarial and to produce no unwanted side effects in animal models. Here, we present the phase 1 clinical trial conducted to evaluate the safety of AS201-01 tablets in healthy volunteers. METHODS: The study was a randomized, double-blind controlled cross-over, a placebo-controlled design consisting of a 4-day treatment of AS201-01 tablets. A total of 30 healthy human volunteers (16 males and 14 females) were divided into two groups, and each group was given 4 tablets, twice daily for 4 days. Group 1 received AS201-01, while group 2 received placebo tablets. Volunteers were given a physical examination before the treatment. The effects of AS201-01 on random blood glucose, biochemical, and hematological as well as urine profiles were investigated. RESULTS: There were no changes in observed parameters as a result of AS201-01 being administered. Statistical analysis showed no significant difference (p>0.05) between the test and control group regarding hematology profile, biochemical profile, and random blood glucose. Increased appetite and better sleep, which categorized as grade 1 adverse event was reported after treatment with AS201-01 tablet. CONCLUSIONS: The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic.
RESUMO
BACKGROUND: Our previous preclinical study showed that the extract mixture (EM) of Andrographis paniculata (Burm. f.) Wall. ex Nees (AP) and Syzygium polyanthum (Wight.) Walp (SP) leaves had antidiabetic effects and were beneficial on alloxan-induced diabetic rats. PURPOSE: The objectives of this study were to: 1) identify the phytochemical compounds present in aqueous extract of AP and SP and 2) examine the benefits of the EM of AP and SP leaves in lowering blood glucose in the presence of standard antidiabetic treatment using metformin in type 2 diabetic patients in Indonesian Traditional Medicine Polyclinic of Dr. Soetomo General Hospital in Surabaya. METHODS: Phytochemical analysis of aqueous leaf extract of AP and SP was performed using standard chemical tests, TLC, and GC-MS. Furthermore, a total of 54 subjects with T2DM participated in this study and were randomly assigned to either the intervention group supplemented with the extract mixture of AP and SP at a dose 900⯠mg/day for 8 weeks, or the control group which received placebo tablets in a randomized placebo-controlled double-blinded parallel clinical trial. Both groups received metformin at dose 1000⯠mg/day. Body weight, blood pressure, fasting blood glucose, postprandial glucose, haemoglobin A1c, triglycerides, total cholesterol, low density lipoprotein, high density lipoprotein, and markers of liver and kidney damage were measured. RESULTS: The results of phytochemical analysis showed that the glycosides, terpenoids, alkaloids, flavonoids, saponins, and tannins were found to be present in the extract mixture. GC-MS analyses of AP and SP showed the presence of 19 and 12 peaks, respectively. Methyl ester of 9-octadecenoic and eicosanoic acid were determined as the main constituents of both species. Moreover, the results of clinical study suggested that the extract mixture improved the decrease of fasting blood glucose and postprandial glucose, significantly lowered body mass index compared with the control group. The EM appeared beneficial for SGPT values and uric acid levels. CONCLUSION: Overall, the results of this study suggested the potential beneficial effects of the extract mixture for use as complementary medicine alongside conventional treatment of metformin. The extract mixture contained many highly potent compounds for treating T2DM and preventing short- and long-term risk complications of diabetes.
