Objective To observe the effect of Qi-strengthening and blood-activating Chinese patent medicine Qigui Ershen Granules on the carotid intima-media thickness(IMT ) , atheromatous plaque scores, serum fibroblast growth factor 23 (FGF23) and Klotho protein levels, and oxidation- and inflammation-associated indicators in carotid atherosclerosis patients. Methods Fifty-two carotid atherosclerosis patients were randomized into Chinese medicine group and western medicine group, 26 cases in each group. Chinese medicine group was treated with Qigui Ershen Granules orally, and western medicine group was treated with Atorvastatin Calcium Tablets orally. The mediation for the two groups lasted for 24 continuous weeks. Carotid ultrasonography was performed before and after treatment for the examination of carotid IMT and plaque Crouse scores. Double antibody sandwich enzyme-linked immunosorbent assay(ELISA) was applied for the detection of serum Klotho, FGF23, interleukin 1(IL-1) and tumor necrosis factorα(TNF-α) levels, and radio-immuno-precitation method was used for the assay of serum reactive oxygen species (ROS), malondialdehyde (MDA) and superoxide dismutase (SOD) levels. The clinical efficacy of the two groups was evaluated by the scores of Qi deficiency syndrome and blood stasis syndrome before and after treatment. Results (1) In western medicine group, 5 cases dropped out and were excluded, and a total of 21 cases completed the trial; in Chinese medicine group, 3 cases dropped out and were excluded, and a total of 23 cases completed the trial.(2) After treatment for 24 continuous weeks, IMT and Crouse scores of the plaque in the two groups were obviously reduced(P < 0.01 compared with those before treatment) , but the differences of IMT and the scores between the two groups were insignificant after treatment(P > 0.05). (3) Serum Klotho protein level was increased while FGF23 was decreased in Chinese medicine group after treatment (P < 0.01 compared with those before treatment); no obvious changes of serum Klotho protein and FGF23 levels were found in western medicine group before and after treatment(P > 0.05). The effects of Chinese medicine on increasing Klotho protein level and decreasing FGF23 level were superior to those of western medicine (P<0.01). (4) After treatment, serum IL-1, TNF-α, ROS and MDA levels were decreased and serum SOD level was increased in the two groups (P < 0.01 compared with those before treatment). The differences of the above indexes were insignificant between the two groups after treatment(P > 0.05).(5) The scores of Qi deficiency syndrome and blood stasis syndrome in Chinese medicine were decreased after treatment (P < 0.01), but showed no significant changes in western medicine group (P > 0.05). Chinese medicine group had better effect on improving the scores of Qi deficiency syndrome and blood stasis syndrome than western medicine group(P < 0.01).(6) After treatment, the total effective rate for improving Qi deficiency syndrome and blood stasis syndrome in Chinese medicine group was 82.61%, 78.26%, and that in western medicine group was 28.57%, 14.28%respectively, the difference being significant (P<0.01). Conclusion Qi-strengthening and blood-activating Qigui Ershen Granules have certain effects on counteracting atherosclerosis, inflammatory aging and oxidation.