Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-22 @ 3:35 PM
Study NCT ID:
NCT07066059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period
Sponsor:
Shandong University
Organization:
Study Overview
Official Title:
Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: