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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Adenoma
• Intervention / Treatment: Drug: Placebo granules; Drug: Jianpi Lishi Jiedu Granules

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wanli Liu; Phone Number: 86 18502506688; Email: njzxjh001@njucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 18 and 80 years, male or female
2. 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
3. Traditional Chinese Medicine (TCM) syndrome type conforms to the Spleen Deficiency and Dampness Toxin syndrome
4. The patient is fully informed, voluntarily consents to data collection, and has signed the informed consent form

Exclusion Criteria:

1. Patients with diseases such as familial polyposis, inflammatory bowel disease, serrated polyposis syndrome, Peutz-Jeghers syndrome, or other hereditary polyposis syndromes
2. Patients with long-term use of medications such as aspirin, metformin, intestinal flora regulators, folic acid, calcium preparations, and vitamin D
3. 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)
4. 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
5. 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
6. Pregnant or lactating women, or patients planning a recent pregnancy
7. Patients with an allergic constitution or a history of allergies to multiple drugs
8. Patients with severe heart, brain, lung, liver, kidney diseases, or mental disorders who cannot tolerate colonoscopy, treatment, and clinical intervention
9. Patients currently participating in other clinical trials or those previously involved in trials related to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	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).
Experimental: Jianpi Lishi Jiedu Granules Group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recurrence rate of colorectal advanced adenomas	At 6 months and 1 year after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Malignant Transformation and Interval Cancer		At 6 months and 1 year after treatment initiation
Quality of Life (KPS Scale)	The Karnofsky Performance Status (KPS) Scale is a standardized tool used to assess the functional status and quality of life of patients. The scale ranges from 0 to 100, with higher scores indicating better quality of life. A score of 100 represents normal function with no complaints or evidence of disease, while a score of 0 indicates death. The interpretation of score changes is categorized as follows: significant improvement (KPS score increase of >20 points), improvement (score increase of 10-20 points), stability (score change of <10 points increase or decrease), and decline (score decrease of >10 points). The score is rated by the investigator based on the patient's clinical status at each time point.	Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
Total Score of the Gastrointestinal Symptom Rating Scale (GSRS)	The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item instrument used to assess gastrointestinal symptoms over the past week. The scale covers five symptom clusters: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is rated on a scale from 0 to 3, where 0 indicates no symptoms and 3 indicates severe symptoms. The total score ranges from 0 to 45, with higher scores indicating worse gastrointestinal symptoms (poorer outcome). The total score is calculated by summing the scores of all 15 items. The scale is administered by the investigator through patient interview at each specified time point.	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	The TCM Syndrome Severity Scale is used to evaluate the severity of Spleen Deficiency and Dampness Toxin syndrome. The scale assesses five primary symptoms (abdominal distension and pain, constipation, diarrhea, poor appetite, dry mouth with sticky sensation) and four secondary symptoms (fatigue and laziness to speak, heavy sensation and drowsiness, nausea and vomiting tendency, borborygmus). Each symptom is rated on a 4-point scale: 0 (none), 1 (mild), 3 (moderate), and 5 (severe). The total score ranges from 0 to 45, with higher scores indicating more severe TCM syndrome symptoms (worse outcome). The total score is calculated by summing the scores of all nine items. The scale is administered by the investigator through patient interview and clinical assessment at each specified time point.	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)	Renal impairment is defined as an increase in serum creatinine level of ≥50% from baseline. Serum creatinine is measured through routine biochemical testing, with units reported in μmol/L or mg/dL. Fasting venous blood samples are collected at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. A participant is considered to have experienced renal impairment if the criterion is met at any of the scheduled visit time points. The final data will be reported as the number and percentage of participants who develop renal impairment.	Baseline (before treatment), 3 months, 6 months, and 1 year after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Levels of Inflammatory Cytokines (Including TNF-α, IL-6, IL-10, IL-17A, IL-1β, IL-4, and IFN-γ)	The concentrations of the following inflammatory cytokines in participants' serum are measured using Enzyme-Linked Immunosorbent Assay (ELISA): tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-17A (IL-17A), interleukin-1β (IL-1β), interleukin-4 (IL-4), and interferon-gamma (IFN-γ). All cytokines are reported in the same unit (pg/mL). Fasting venous blood samples (5ml) are collected in the morning at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. Samples are centrifuged to separate serum, stored at -80°C, and tested uniformly. For each inflammatory cytokine, the mean, standard deviation, and change from baseline are reported at each time point. If data are normally distributed, they are described as mean ± standard deviation; if not normally distributed, they are described as median and interquartile range.	Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
Number of Participants with Drug-Induced Liver Injury (DILI) as Defined by Hy's Law Criteria	Drug-induced liver injury (DILI) is assessed using the Hy's Law criteria, which requires meeting all three of the following conditions: (1) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation ≥ 3 times the upper limit of normal (ULN); (2) total bilirubin (TBil) elevation ≥ 2 times the ULN; (3) alkaline phosphatase (ALP) within normal range (< 2 times ULN), indicating no biliary obstruction. Other causes of liver injury, such as viral hepatitis, alcoholic liver disease, and autoimmune liver disease, must be excluded. ALT, AST, TBil, and ALP are measured through routine liver function biochemical tests. Fasting venous blood samples are collected at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. A participant is considered to have experienced DILI if all three criteria are met at any of the scheduled visit time points. The final data will be reported as the number and percentage of participants who develop DILI.	Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
Gut Microbiota Alpha Diversity Indices Assessed by 16S rRNA Sequencing	Fresh fecal samples (approximately 5g) are collected from participants. Bacterial genomic DNA is extracted, and gut microbiota analysis is performed using 16S rRNA gene sequencing (targeting the V3-V4 hypervariable region). The alpha diversity indices include: Chao1 index (reflecting species richness), Shannon index (reflecting species richness and evenness), and Simpson index (reflecting species dominance). These indices are dimensionless; higher values indicate better microbial diversity. Data are presented as mean ± standard deviation or median (interquartile range).	Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
Gut Microbiota Beta Diversity Assessed by 16S rRNA Sequencing	Fresh fecal samples (approximately 5g) are collected from participants. Bacterial genomic DNA is extracted, and gut microbiota analysis is performed using 16S rRNA gene sequencing (targeting the V3-V4 hypervariable region). Beta diversity is assessed using principal coordinate analysis (PCoA) based on Bray-Curtis distance to evaluate differences in microbial composition between samples. Results are visualized graphically to show clustering of samples across groups, and permutational multivariate analysis of variance (PERMANOVA) is used to compare the significance of differences between groups.	Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
Gut Microbiota Relative Abundance at Phylum, Class, Order, Family, and Genus Levels Assessed by 16S rRNA Sequencing	Fresh fecal samples (approximately 5g) are collected from participants. Bacterial genomic DNA is extracted, and gut microbiota analysis is performed using 16S rRNA gene sequencing (targeting the V3-V4 hypervariable region). Relative abundance of gut microbiota is assessed at various taxonomic levels (phylum, class, order, family, genus). Relative abundance is expressed as percentages (%), and differentially abundant taxa between groups are compared using statistical methods. Data are presented as mean ± standard deviation or median (interquartile range) for the average relative abundance of each taxon.	Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Collaborators: Kunshan Hospital of Traditional Chinese Medicine; Jiangsu Province Hospital with Integration of Chinese and Western Medicine; Affiliated Hospital of Nanjing University of Chinese Medicine; Changzhou Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KY20260305-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No