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

March 26, 2026 updated by: Nanjing First Hospital, Nanjing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
recurrence rate of colorectal advanced adenomas
Time Frame: At 6 months and 1 year after treatment initiation
At 6 months and 1 year after treatment initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Malignant Transformation and Interval Cancer
Time Frame: At 6 months and 1 year after treatment initiation
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
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)
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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)
Time Frame: Baseline (before treatment), 3 months, 6 months, and 1 year after treatment
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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
Time Frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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