Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

NCT06927258 | Enrolling By Invitation

• 1 other identifier: 2024-0661
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Polyps

Keywords

colorectal polyps

Outcome Measures

Primary Outcomes (5)

• serum interleukin-6

  From enrollment to the end of treatment at 2 weeks

• The incidence of complications

  The incidence of complications (blood in stool, perforation) and postoperative discomfort symptoms (abdominal pain, abdominal distension, diarrhea, constipation, fatigue, fever, etc.) were compared between the experimental group and the control group (primary endpoints).

  From enrollment to the end of treatment at 2 weeks

• white blood cells

  From enrollment to the end of treatment at 2 weeks

• C-reactive protein

  From enrollment to the end of treatment at 2 weeks

• erythrocyte sedimentation rate

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (2)

• hospital stay

  From enrollment to the end of treatment at 2 weeks

• hospitalization costs

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

The Changyanning group

ACTIVE COMPARATOR

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.

Drug: changyanning granules

The control group

PLACEBO COMPARATOR

The control group does not use Changyanning granules.

Drug: Placebo

Interventions

changyanning granules DRUG

From one day before the procedure to five days postoperatively, patients in the experimental group will be administered Chanyanning granules.

Also known as: control

The Changyanning group

Placebo DRUG

control

The control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: April 15, 2025
• Study Start: November 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2024-08

Locations

CN (1)