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Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period

NCT07066059 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-15

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust/defecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. The study involves participants aged 18-70 years, both male and female, with ASA grade I-III scheduled for elective surgery. The main questions it aims to answer are:

Can Shouhui Tongbian Capsules shorten the intestinal function recovery time (first flatus and defecation time) in perioperative patients? Can Shouhui Tongbian Capsules improve defecation quality (assessed by Bristol Stool Scale) and reduce inflammatory factor levels (e.g., IL-6, TNF-α)? Researchers will compare the experimental group (receiving Shouhui Tongbian Capsules 2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen) to the control group (receiving routine perioperative care including diet control and standard bowel-cleansing drugs) to see if the capsules show superior efficacy in intestinal function recovery and safety.

Participants will:

Take Shouhui Tongbian Capsules according to the specified regimen (experimental group) or receive routine care (control group).

Have their exhaust/defecation status recorded every 6 hours postoperatively. Undergo blood tests for liver/kidney function and inflammatory factors on the day before surgery and day 3 postoperatively.

Complete questionnaires on bowel preparation comfort and postoperative defecation satisfaction.

Conditions

  • Perioperative Period

Interventions

DRUG

Shouhui Tongbian Capsules

2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen

Sponsors & Collaborators

  • Shandong Public Health Clinical Center

    collaborator OTHER_GOV

  • Shandong University

    lead OTHER

Principal Investigators

  • Qiang Zhang · Shandong Public Health Clinical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-03-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066059 on ClinicalTrials.gov