Hanif Nasiatul Baroroh, Zullies Ikawati, Kartono Sudarman
Objective: The effect of extract combination of legundi (Vitex trifolia L) leaves and temulawak (Curcuma xanthorrhiza Roxb) rhizomes was investigated preclinically as anti allergy.
Methods: This formula have been proven relatively non-toxic. Based on these preliminary studies, this formula was then studied in phase I clinical trials to determine the safety and tolerability of the extract in healthy volunteers.The trial was designed as randomized and double blind study with 30 healthy volunteers divided into 3 groups. Each participants in group 1, 2, and 3 received extract combination of legundi leaves and temulawak rhizomes with the dose of 1500 mg/day, 4500 mg/day, and 9000 mg/day, respectively. Drugs will be administered orally three times daily for 14 days. The primary outcome measured were the absence of tolerability and side effects. The secondary outcome measured were value changes in renal, liver function and physical examination before and after drug administration (pre and post control group design).
Results: The results showed that the extract combination at the dose of 1500 mg/day and 4500 mg/day were well tolerated and safe, as seen from the absence of the drug-induced changes in the renal and liver function. However, there were significant changes in the value of AST and serum creatinine after administration of the extract combination with the dose of 9000 mg/day (p <0.05). There were no significant side effects in the Group 1 and 2, while the thrush and decrease of blood pressure were reported with administration of the doses of 9000 mg/day. Thus, extract combination of legundi leaves and temulawak rhizomes at the dose of 1500 mg/day and 4500 m /day were found to be well tolerated and safe.
