Rosacea encompasses a constellation of clinical pathologies, including persistent erythema, inflammatory papulopustular rash, and facial telangiectasias. Additionally, rosacea is considered to be an important risk factor for various diseases, and it has been suggested to be related with inflammatory bowel disease, cardiovascular disease, hyperlipidemia, Parkinson's disease, rheumatoid arthritis, malignant tumor, autoimmune diseases and so on. 1,2,3) The major pathomechanisms of rosacea are environmental triggers (e.g., heat and alcohol) and genetic predisposition, which play a major role in neurovascular dysregulation. Other pathogenic factors of rosacea include ultraviolet radiation, skin barrier dysfunction, demodicosis and infection of Staphylococcus. Moreover, the improper and excessive use of topical corticosteroid creams on the face causes rosacea-like symptoms (steroid-induced rosacea). 4) Recently, some studies have reported the importance of oxidative stress in the pathophysiology of rosacea about vascular lesions, inflammation, and oxidative tissue damage. 5,6,7) The Rosacea Medical Management Guidelines of the American Acne and Rosacea Society 8) recommend certain topical and oral therapies for papules and pustules. Currently, standard medical and surgical therapies for rosacea include topical agents such as azelaic acid, metronidazole, and brimonidine tartrate; systemic doxycycline and isotretinoin; and vascular laser therapy; 9,10) however, the therapeutic effect of the current treatment is rather limited, only palliative for a short span, and cannot prevent recurrence in many cases. In particular, telangiectasia and flushing, the clinical symptoms of rosacea, are only treated with the use of light devices, with weak trial evidence. Similarly, according to the guidelines of the Japanese Dermatological Association, many options for the treatment of acne vulgaris are ranked A ("highly recommended"), while most of the options for treating rosacea are ranked as only either C1 ("conditionally recommended") or C2 ("not recommended"). 11) Therefore, as mentioned above, the treatment recourse for the clinical symptoms of rosacea has not yet been sufficiently established.However, some pharmaceutical-grade traditional Japanese medicines (Kampo) show antioxidative and antibacterial effects, especially the improvement of blood flow, and it has been reported that treatment with a traditional Kampo medicine has alleviated rosacea symptoms in many cases. 12) In Kampo medicine, pathological changes in the capillaries of rosacea patients are considered the "Oketsu" state. 13) Oketsu is similar in concept to blood stasis, but it is the characteristic pathophysiology in traditional Japanese medicine that describes a circulatory disturbance with vascular resistance and blood fluidity.The Keishi-Bukuryo-gan-ka-Yokuinin (KBY) is one of the pharmaceutical-grade traditional Kampo, generally prescribed for Oketsu and has been widely used for the treatment of menstrual irregularity, automatic imbalance syndrome peculiar to wo...