The aim of the study was to investigate clinical efficacy of the medical complex Galavit in patients with acute phase of duodenal ulcer (DU) in. The subjects were 60 DU patients aged 32 +/- 2 years with ulcerous defects of 0.4 to 1.3 cm in diameter. In patients receiving Galavit, pain was coped with by Mann-Whitney method in 2.5 +/- 0.2 days, p < 0.001; in the control group--in 5.7 +/- 0.1 days. In the Galavit group the ulcers healed in 11.3 +/- 0.2 days, p < 0.001; in the control group--17.8 +/- 0.3 days; in 4 cases (13.3%) the ulcerous defects healed with forming of rough scars. Galavit elevated T-lymphocyte rate from 53.1 +/- 0.6% to 65.1 +/- 0.2%, p < 0.001; T-helper inductor level--from 27.8 +/- 0.2% to 38.5 +/- 0.3%, p < 0.001; cytotoxic T-lymphocyte level--from 18.5 +/- 0.5% to 27.3 +/- 0.3%, p < 0.001; B-lymphocyte level--from 12.3 +/- 0.2% to 19.1 +/- 0.1%, p < 0.001. The therapy significantly lowered malonic aldehyde level by 23.5%, trienoic conjugate level--by 61.6%; superoxide dismutase level rose 1.6 times, catalase level--1.4 times, glutathion reductase level--from 19.03 +/- 1.17 to 27.01 +/- 1.24 optical density units/mg, p < 0.001. The study did not find any significant changes in the immune status and lipid peroxidative/antioxidative system of patients receiving basic therapy. The results show that Galavit has anti-inflammatory effect, improves immune status and anti-oxidative protection. It is appropriate to administer Galavit as a component of DU basic therapy. The results show that Galavit has anti-inflammatory effect, improves immune status and anti-oxidative protection. It is appropriate to administer Galavit as a component of DU basic therapy.