Objectives: To assess the eficacy of Fuhuang Tablets in treating internal hemorrhoid hemor-rhage and discussing the design and quality control of clinical trials of traditional Chinese medicine. Methods: According to two-center, random ized, bIinded and controlled study. 144 patients with internaI hemorrhoids were divided into 2 groups. Seventy-two patients were treated with Fuhuang Tablets (4 tablets t. i. d. per OS) and the other 72 patients were treated with Zhining Tablets (4 tablets t. i. d. per os. Symptoms and signs of the patients were recorded and evaluated at the third and seventh day of treatment respectively. Results: At the third day of treatment, the overall response rates of Fuhuang Tablets-treated group and ZhiningTablets. treated group were 58.57% and 27.78% respectively, with statistic diference between the two groups (P<0.05). At the seventh day of treatment. the overall response rates of Fuhuang Tablets. treated group and Zhining Tablets-treated group were 9 1.43% and 81.94% respectively. with no statistic diference between the two groups. The laboratory test results and Iife signs of the 1 44 patients were normal before and after the treatment. Conclusion: Fuhuang Tablets are efective and safe in treating internal hemorrhoid hemorrhage.