Chinese herbal extract granules combined with 5- aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo- controlled trial Zhaofeng Shen Aliated Hospital of Nanjing University of Chinese Medicine https://orcid.org/0000-0002-7914-3965 Kai Zheng Department of Gastroenterology,Jiangsu Province Hospital of Chinese Medicine Jiandong Zou Aliated Hospital of Nanjing University of Chinese Medicine Peiqing Gu Jiangsu Province Academy of Traditional Chinese Medicine Jing Xing Michigan State University Eli Broad College of Business Lu Zhang Department of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine Lei Zhu (
[email protected] ) Hong Shen Department of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine Study protocol Keywords: Ulcerative colitis, Chinese herbal medicine, 5-aminosalicylic acid, Multicenter randomized controlled trial, Study protocol Posted Date: January 11th, 2021 DOI: https://doi.org/10.21203/rs.3.rs-29723/v2 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/19 Version of Record: A version of this preprint was published on January 13th, 2021. See the published version at https://doi.org/10.1186/s13063-020-05012-8. Page 2/19 Abstract Background: Ulcerative colitis (UC) is an intestinal inammatory disease characterized by inammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients with moderately active UC, several therapies (e.g. aminosalicylates, corticosteroids, immunosuppressants and biologics) are recommended for induction (or maintenance) of remission. Given the side effects and disease burden, it is dicult for most patients to achieve ideal treatment goals in clinical practice.