This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Jianpi Lishi Jiedu Granules in preventing postoperative recurrence of colorectal advanced adenoma. A total of 376 patients aged 18-80 years with endoscopically resected advanced adenoma and diagnosed with Spleen Deficiency and Dampness Toxin syndrome will be enrolled and randomly assigned to receive either Jianpi Lishi Jiedu Granules or placebo for 3 months. The primary endpoint is the adenoma recurrence rate at 1 year post-treatment, assessed by colonoscopy and pathological examination. Secondary endpoints include malignant transformation rate, TCM syndrome improvement, quality of life, gastrointestinal symptoms, and exploratory analyses of gut microbiota and inflammatory cytokines.
Aged between 18 and 80 years, male or female
Have undergone endoscopic resection of colorectal adenoma within the past 2 weeks (cold snare resection or endoscopic mucosal resection for adenomas < 20 mm, or endoscopic submucosal dissection for adenomas ≥ 20 mm), and have been diagnosed with colorectal advanced adenoma by endoscopy and pathology
Traditional Chinese Medicine (TCM) syndrome type conforms to the Spleen Deficiency and Dampness Toxin syndrome
The patient is fully informed, voluntarily consents to data collection, and has signed the informed consent form
Patients with diseases such as familial polyposis, inflammatory bowel disease, serrated polyposis syndrome, Peutz-Jeghers syndrome, or other hereditary polyposis syndromes
Patients with long-term use of medications such as aspirin, metformin, intestinal flora regulators, folic acid, calcium preparations, and vitamin D
Patients with a bleeding tendency (referring to a pathological state where hemostasis is difficult after spontaneous bleeding or minor trauma due to coagulation dysfunction or vascular structural issues) or those currently using anticoagulant medications (e.g., aspirin, clopidogrel)
Patients in the active phase of inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, etc.), with a history of intestinal bleeding, or a history of intestinal surgery
Nanjing First Hospital, Nanjing Medical University
Lead sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborator
Changzhou Hospital of Traditional Chinese Medicine
Collaborator
Kunshan Hospital of Traditional Chinese Medicine
Collaborator