Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

April 13, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The Changyanning group
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
From one day before the procedure to five days postoperatively, patients in the experimental group will be administered Chanyanning granules.
Other Names:
  • control
Placebo Comparator: The control group
The control group does not use Changyanning granules.
Drug: Placebo
control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum interleukin-6
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks
The incidence of complications
Time Frame: From enrollment to the end of treatment at 2 weeks
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
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks
C-reactive protein
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks
erythrocyte sedimentation rate
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
hospital stay
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks
hospitalization costs
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0661

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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