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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShandong University

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18-70 years, regardless of gender;

ASA class I-III, elective surgery patients;

Signed the informed consent form.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Shouhui Tongbian Capsules

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shandong University

Lead sponsor

Shandong Public Health Clinical Center

Collaborator