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Enrolling by invitation NCT06927258

Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

No phase Interventional Colorectal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: changyanning granules, Placebo.
Who it may be relevant to
Registry conditions: Colorectal Polyps. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • serum interleukin-6 [Time frame: 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]
  • white blood cells [Time frame: 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]
  • erythrocyte sedimentation rate [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (2)
  • hospital stay [Time frame: From enrollment to the end of treatment at 2 weeks]
  • hospitalization costs [Time frame: From enrollment to the end of treatment at 2 weeks]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT06927258 · 2024-0661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗