Previously, two case-control studies and a cohort study strongly suggested that Panax ginseng C.A. Meyer exerted non-organ-specific preventive effects against cancer. The purpose of the present study was to evaluate the effects of red ginseng extract on the incidence of human primary cancer.We conducted a randomized, double-blinded, placebo-controlled trial on 643 chronic atrophic gastritis patients in four hospitals in Zhejiang Province, China. Red ginseng extract powder (1 g) was administered orally to each patient per week for 3 years and followed up for 8 years. The development of various cancers in the red ginseng subjects was compared to that of a placebo group. The red ginseng extract powder was specified in terms of its components. Twenty-four cancers of various organs were diagnosed from these subjects during the 11 years: eight lung cancers, six stomach cancers, two liver cancers, two colorectal cancers, and one cancer each of the nasopharynx, esophagus, pancreas, urinary bladder, prostate, and gallbladder. The red ginseng group, which included both genders, demonstrated a relative cancer risk of 0.54 (95% confidence interval, 0.23-1.28; P=.13) compared to the placebo group, which was not statistically significant. Among the 24 cancer patients, 21 were male. The male red ginseng group showed a relative cancer risk of 0.35 (95% confidence interval, 0.13-0.96; P=.03) compared to the male placebo group, which was highly significant statistically. In the present clinical trial on chronic atrophic gastritis patients, administration of red ginseng extract powder for 3 years exerted significant preventive effects on the incidence of non-organ-specific human cancers in males.