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

NCT07066059 | Not Yet Recruiting Early Phase 1

• 1 other identifier: SDU-2025-XM-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Period

Outcome Measures

Primary Outcomes (4)

• Postoperative intestinal function recovery time

  Observe and record the postoperative intestinal function recovery time of the two groups of patients (including the time of first exhaust and defecation). The shorter the time, the better.

  Throughout the study drug treatment period, about 2 weeks

• Total duration of intestinal function recovery

  Observe and record the total duration of intestinal function recovery of the two groups of patients. The shorter the time, the better.

  Throughout the study drug treatment period, about 2 weeks

• Defecation trait score

  Observe and record the defecation trait score of the two groups of patients (using the Bristol Stool Scale). Seven types of stools based on shape and consistency, with type 1 being the hardest and type 7 being the softest

  Throughout the study drug treatment period, about 2 weeks

• Levels of inflammatory factors

  Measure the levels of inflammatory factors (such as IL-6, TNF-α, etc.).

  Throughout the study drug treatment period, about 2 weeks

Secondary Outcomes (3)

• Adverse event rate

  Throughout the study drug treatment period, about 2 weeks

• Comfort of intestinal preparation satisfaction questionnaire

  Throughout the study drug treatment period, about 2 weeks

• Postoperative defecation satisfaction questionnaire

  Throughout the study drug treatment period, about 2 weeks

Study Arms (2)

Standard Treatment group

NO INTERVENTION

Receive routine perioperative care including diet control and standard bowel-cleansing drugs

Shouhui Tongbian Capsules group

EXPERIMENTAL

Receive Shouhui Tongbian Capsules

Drug: Shouhui Tongbian Capsules

Interventions

Shouhui Tongbian Capsules DRUG

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

Shouhui Tongbian Capsules group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years, regardless of gender;
• ASA class I-III, elective surgery patients;
• Signed the informed consent form.

You may not qualify if:

• Digestive system diseases: intestinal obstruction, intestinal perforation, acute peritonitis; inflammatory bowel disease (ulcerative colitis, Crohn's disease); gastrointestinal tumors (primary or metastatic); severe hemorrhoids or anal fissures (grade Ⅲ-Ⅳ); severe liver disease (Child-Pugh class ≥ B); Other systemic diseases: severe cardiovascular diseases (cardiac function grade Ⅲ or above, severe arrhythmia); uncontrolled diabetes (fasting blood glucose \> 11.1 mmol/L); autoimmune diseases (such as active systemic lupus erythematosus, rheumatoid arthritis); advanced malignant tumors or during radiotherapy/chemotherapy.
• Liver and kidney function abnormalities:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal (ULN); serum creatinine (Cr) \> 1.5 times ULN; estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m².
• Use of the following drugs within the past 2 weeks:
• Laxatives (e.g., lactulose, polyethylene glycol), gastrointestinal motility agents (e.g., domperidone, mosapride), antibiotics (systemic use), opioid analgesics, anticholinergic drugs, long-term laxative use (continuous use ≥ 2 weeks), preoperative use of enteral nutrition preparations or intravenous nutritional support.
• Pregnant or lactating women; those allergic to components of Shouhui Tongbian Capsules (including Chinese herbal ingredients such as ginseng, atractylodes, polygonum multiflorum); patients with mental disorders or cognitive impairment; emergency or urgent surgery patients; those with an expected postoperative hospital stay \< 3 days.
• Participation in other clinical trials without passing the washout period; other situations where the investigator deems the subject unsuitable for the study.

Sponsors & Collaborators

• Shandong University: lead
• Shandong Public Health Clinical Center: collaborator

Study Sites (1)

Shandong Public Health Clinical Center

Jinan, China

Location

Study Officials

• Qiang Zhang

  Shandong Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)