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Enrolling by Invitation

NCT Number: NCT06927258

Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

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.

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Key information

Conditions

Colorectal Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

changyanning granules

Drug

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

Other names: control

Placebo

Drug

control

Primary outcomes

  1. serum interleukin-6

    Time frame: From enrollment to the end of treatment at 2 weeks

  2. 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).

  3. white blood cells

    Time frame: From enrollment to the end of treatment at 2 weeks

  4. C-reactive protein

    Time frame: From enrollment to the end of treatment at 2 weeks

  5. erythrocyte sedimentation rate

    Time frame: From enrollment to the end of treatment at 2 weeks

Secondary outcomes

  1. hospital stay

    Time frame: From enrollment to the end of treatment at 2 weeks

  2. hospitalization costs

    Time frame: From enrollment to the end of treatment at 2 weeks

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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