Abstract: AIM: To evaluate the efficacy and safety of yanshenjianwei capsules in the treatment of patients with chronic atrophic gastritis.METHODS: Yanshenjianwei capsule was observed in a randomized, doubleblind, double-modeling, and apositive drug-controlled clinical trail. 202 patients were divided into two groups: yanshenjianwei capsule group (n =103) and control group (n =99).The symptoms of the traditional Chinese medicine were observed. Atrophy of glandular organ in gastric mucosa, intestinal metaplasia and atypical hyperplasia were observed by gastroscope and biopsy of gastric mucosa.RESULTS: The cure rate of the yanshenjianwei capsule group and the control group were 21. 36 % and 14. 14 % on the symptoms of pathology, and the effective rate were 28. 16 % and 16. 16 %, respectively. The yanshenjianwei capsule group was superior to the control group (P<0. 05).The cure rate of the yanshenjianwei capsule group and the control group were 25. 24 % and 12. 12 %on the symptoms of the traditional Chinese medicine, and the effective rate were 16. 16 % and 36. 36 %, respectively. There was a significantly statistical difference between the two groups (P<0. 05).No serious side effects were found on blood-routine, urine-routine, stool-routine, electrocardiogram, liver function and kidney function in the two groups.CONCLUSION: Yanshenjianwei capsule is an effective and safe drug for patients with chronic atrophic gastritis and cold-heat complicated syndromes in TCM.

Key words: yanshenjianwei capsule, danguixiang granule, chronic atrophic gastritis, cold-heat complicated syndrome, clinical trial