ABSTRACT
The clinical study was conducted to further evaluation the effectiveness and safety of Fangfeng Tongsheng granule in the treatment of sub-acute eczema (superficial cold and interior heat syndrome, exterior and interior sthenic syndrome). In the block randomized, multi-centered study, totally 108 patients were enrolled and assigned to two groups: 72 patients in the test group and 36 patients in the placebo control group. Those in the test group took Fangfeng Tongsheng granule with the dose of 3 g, twice a day, while those in the control group were give simulated agent granules with the same dose. The therapeutic course lasted for 14 days. Their efficacies in TCM syndrome, dermal symptoms and adverse events were observed. According to the test results, except for the one exit case, all of the remaining 108 cases, including 71 in the test group, and 36 in the control group, completed the clinical trial. As for the efficacy of TCM syndrome, after the medication for 2 weeks, the cure rate was 33.81% (24/71) in the test group and 0% (0/36) in the control group (P < 0.01), with a statistical difference between the two groups. Regarding the TCM score, after the medication for 2 weeks, the test group decreased by (12.82 +/- 7.96), while the control group decreased by (3.67 +/- 4.12), indicating a statistical difference between the two groups. As for the efficacy of dermal symptoms, after the medication for 2 weeks, the cure rate was 25.35% (18/71) in the test group and 0% (0/36) in the control group, with a statistical difference between the two groups. Regarding the dermal symptom score, after the medication for 2 weeks., the test group decreased by (10.04 +/- 7.17), while the control group decreased by (2.33 +/- 3.57), indicating a statistical difference between the two groups. There was no significant adverse event caused by Fangfeng Tongsheng granule. In conclusion, Fangfeng Tongsheng granule was effective and safe in treating subcute eczema (superficial cold and interior heat syndrome, exterior and interior sthenic syndrome).