Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

NCT ID: NCT06927258

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

changyanning granules

Intervention Type DRUG

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

The control group

The control group does not use Changyanning granules.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

control

Interventions

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changyanning granules

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

Intervention Type DRUG

Placebo

control

Intervention Type DRUG

Other Intervention Names

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control

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2024-0661

Identifier Type: -

Identifier Source: org_study_id

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