Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

Zhejiang University

Status: Invitation-only

Conditions: Colorectal Polyps

Treatments: Drug: changyanning granules; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06927258

2024-0661

Details and patient eligibility

About

This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (EMR, hybrid ESD, ESD).

Exclusion criteria

• Concurrent infectious diseases or malignant tumors; Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups, including a placebo group

The Changyanning group

Active Comparator group

Description:

The Changyanning group takes Changyanning granules starting from 1 day before surgery until 5 days after surgery. The granules are taken preoperatively at the same time as the first dose of laxative, and postoperatively starting after resuming an open diet.

Treatment:

Drug: changyanning granules

The control group

Placebo Comparator group

Description:

The control group does not use Changyanning granules.

Treatment:

Drug: Placebo