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A multicenter, randomized, double-blind, parallel-controlled clinical study on the intervention of Jianpi Lishi Jiedu Granules for postoperative recurrence of 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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128330
Enrollment
Unknown
Registered
2026-07-17
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal advanced adenomas with spleen deficiency and dampness toxin syndrome after endoscopic resection

Interventions

Experimental Group:Jianpi Lishi Jiedu Granules

Sponsors

Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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), 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

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.

Design outcomes

Primary

MeasureTime frame
recurrence rate of colorectal advanced adenomas;

Secondary

MeasureTime frame
malignant transformation and interval cancer;Inflammatory Cytokines;Drug-Induced Liver Injury (DILI);Renal Impairment;Gut Microbiota;Quality of Life (KPS Scale);Gastrointestinal Function (GSRS);TCM Syndrome Efficacy;

Countries

China

Contacts

Public ContactWanli Liu

Nanjing First Hospital

18951768998@163.com+86 25 8537 0998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026