Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas

Official title

A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study on the Intervention of Jianpi Lishi Jiedu Granules for Postoperative Recurrence of Colorectal Advanced Adenomas

Overview

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.

Interventions

• Drug Jianpi Lishi Jiedu Granules
  The intervention is orally administered as one sachet of Jianpi Lishi Jiedu Granules, twice daily (1 hour after breakfast and dinner), for a treatment course of 3 months. All participants will begin medication after resuming oral intake following surgery for colorectal advanced adenoma (≥2 weeks post-procedure).
• Drug Placebo granules
  Participants in the control group will receive placebo granules orally (with the same specifications, appearance, dosage, and administration as the experimental group) for a treatment course of 3 months. All participants will begin medication after resuming oral feeding following surgery for colorectal advanced adenoma (≥2 weeks post-procedure).

Primary outcome measures

• recurrence rate of colorectal advanced adenomas [Time frame: At 6 months and 1 year after treatment initiation]

Secondary outcome measures (5)

• Number of Participants with Malignant Transformation and Interval Cancer [Time frame: At 6 months and 1 year after treatment initiation]
• Quality of Life (KPS Scale) [Time frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment]
• Total Score of the Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment]
• Total Score of the Traditional Chinese Medicine (TCM) Syndrome Severity Scale [Time frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment]
• Number of Participants with Renal Impairment (Defined as Serum Creatinine Increase ≥50% from Baseline) [Time frame: Baseline (before treatment), 3 months, 6 months, and 1 year after treatment]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• Patients with high-grade intraepithelial neoplasia involving the vascular system, lymphatic tumor thrombi, or small arteries; patients with biopsy pathology confirming suspected malignancy or established malignancy
• Pregnant or lactating women, or patients planning a recent pregnancy
• Patients with an allergic constitution or a history of allergies to multiple drugs
• Patients with severe heart, brain, lung, liver, kidney diseases, or mental disorders who cannot tolerate colonoscopy, treatment, and clinical intervention
• Patients currently participating in other clinical trials or those previously involved in trials related to this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07505056 · KY20260305-07

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗