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Randomized, Double-Blind, Placebo-Controlled Trial Protocol of AI-Optimized Formula Granules for Preventing Postoperative Recurrence of Colorectal Adenoma

Demonstration and Application of Innovative Traditional Chinese Medicine for Postoperative Recurrence Intervention in Artificial Intelligence and Data-Driven Colorectal Adenomas, and Evaluation of Clinical Value

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001502
Enrollment
Unknown
Registered
2026-06-17
Start date
2026-12-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Colorectal adenoma

Interventions

Experimental group:Oral Chinese herbal granules
control group:Oral placebo

Sponsors

Wangjing Hospital of the China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet all 6 of the following criteria to be eligible for this study: 1) Aged 18–75 years; gender is not restricted. 2) Patients diagnosed via colonoscopy within the past 6 months and who have undergone complete endoscopic resection of pathologically confirmed advanced colorectal adenomas (including villous adenomas, tubular-villous adenomas, and tubular adenomas). Patients must have histologically confirmed presence of 1–6 colorectal adenomas. 3) With or without symptoms such as constipation, diarrhea, or abdominal distension. 4) Boston Bowel Preparation Score = 6. 5) Familial adenomatous polyposis or polyposis has been ruled out based on medical and family history. 6) Willing to participate and has signed an informed consent form.

Exclusion criteria

Exclusion criteria: Patients meeting any one or more of the following criteria should be excluded: 1) Patients with adenomas that were not completely resected during a previous colonoscopy; 2) Patients with polyps that have already undergone malignant transformation, or those with familial adenomatous polyposis; 3) Patients on long-term therapy with aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, vitamin D, or calcium supplements, or those undergoing long-term systemic immunotherapy; 4) Patients unable to tolerate colonoscopy; 5) Patients with inadequate bowel preparation for colonoscopy or whose examination duration was less than 6 minutes; 6) Patients with acute or chronic conditions that may significantly affect treatment and prognosis, such as severe cardiovascular or cerebrovascular disease, severe liver or kidney disease, or serious postoperative complications; 7) Pregnant women, women planning to become pregnant, or breastfeeding women; 8) Patients with allergies or contraindications to the relevant medications; 9) Patients with underlying psychiatric disorders that prevent them from cooperating fully with the trial; 10) Patients with concurrent malignant tumors; 11) Patients currently participating in other clinical trials within the past month; 12) Other circumstances deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Adenoma recurrence rate;

Secondary

MeasureTime frame
Gastrointestinal Symptom Scale Score;Anxiety;Depression;Number and nature of intestinal polyps;

Countries

China

Contacts

Public Contactwang xin

Wangjing Hospital China Academy of Traditional Chinese Medicine

18811502965@163.com18811502965

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026