To observe the clinical efficacy of Xiaojin Capsule combined with Chinese herbal mask in the treatment of moderate and severe acne with phlegm and blood stasis，and to evaluate the correlation between the efficacy and the grades(Ⅱ，Ⅲ and Ⅳ) of acne.Methods:A total of 80 moderate and severe acne patients with phlegm and blood stasis admitted to Dongfang Hospital of Beijing University of Chinese Medicine from February 2019 to December 2019 were selected as the study objects.They were divided into observation group and control group using random number table method，with 40 in each group.The observation group was given Xiaojin Capsule orally，while the control group was given Tanshinone Capsule orally.Additionally，the two groups were given external application of Chinese herbal mask.The treatment lasted for 4 weeks.The scores of skin lesions，traditional Chinese medicine(TCM) syndromes and quality of life in the two groups were compared，and the correlation between the improvement in the three scores and acne grades was analyzed.Moreover，the adverse reactions were recorded.Results:A total of 73 effective cases were collected，including 38 in observation group and 35 in control group.The total effective rate of skin lesions in observation group was 92.11%，higher than 68.57% in control group(P<0.01).The total effective rate of TCM syndromes in observation group was 94.74%，higher than 68.57% in control group(P<0.01).There was difference in the change of TCM syndrome score in observation group in different acne grades(P<0.05).Specifically，the change rate of grade Ⅱ and grade Ⅲ patients was higher than that of grade Ⅳ patient(P<0.05).During treatment，no adverse reaction was found in observation group，while there were 2 cases of adverse reactions in control group，which were relieved after discontinuation.Conclusion:Xiaojin Capsule combined with Chinese herbal mask shows definite curative efficacy and high safety in treating moderate and severe acne with phlegm and blood stasis.There is a relationship between TCM syndromes and acne grades，and the therapeutic effect of grades Ⅱ and Ⅲ patients is more obvious than that of grade Ⅳ patients.