Colorectal AdenomaPhase 3NCT07505056
Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas
A Phase 3 study testing Jianpi Lishi Jiedu Granules in people with Colorectal Adenoma, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Jianpi Lishi Jiedu Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 29 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Colorectal Adenoma
- Being tested
- Jianpi Lishi Jiedu Granules, Placebo granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianpi Lishi Jiedu GranulesDrug
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).
Placebo granulesDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo granules |
| Jianpi Lishi Jiedu Granules Group | Experimental | Not described Receives: Drug: Jianpi Lishi Jiedu Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of colorectal advanced adenomas
Measured: At 6 months and 1 year after treatment initiation
Secondary outcomes (5)
Number of Participants with Malignant Transformation and Interval Cancer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before treatment), 3 months, 6 months, and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505056
- Sponsor's protocol ID
- KY20260305-07
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07505056
- Acronym / sponsor ID
- KY20260305-07
- Conditions
- Colorectal Adenoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo granules |
| Jianpi Lishi Jiedu Granules Group | Experimental | Drug: Jianpi Lishi Jiedu Granules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jianpi Lishi Jiedu GranulesThe 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 | Jianpi Lishi Jiedu Granules Group |
| Placebo granulesParticipants 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). | Drug | Placebo Group |
Primary outcome
recurrence rate of colorectal advanced adenomas
Time frame: At 6 months and 1 year after treatment initiation
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jianpi Lishi Jiedu Granules in people with Colorectal Adenoma, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanli Liu (86 18502506688, njzxjh001@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of colorectal advanced adenomas (time frame: At 6 months and 1 year after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.