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

NCT ID: NCT07066059

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Shouhui Tongbian Capsules group

Receive Shouhui Tongbian Capsules

Group Type: EXPERIMENTAL

Shouhui Tongbian Capsules

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18-70 years, regardless of gender;

2. ASA class I-III, elective surgery patients;

3. Signed the informed consent form.

Exclusion Criteria

1. Disease-related exclusions:

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.

2. 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.

3. Medication-related exclusions:

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.

4. Exclusions for special populations:

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.

5. Other exclusions:

Participation in other clinical trials without passing the washout period; other situations where the investigator deems the subject unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Public Health Clinical Center

OTHER_GOV

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiang Zhang

Role: PRINCIPAL_INVESTIGATOR

Shandong Public Health Clinical Center

Locations

Shandong Public Health Clinical Center

Jinan, , China

Countries

China

Central Contacts

Wei Zhao, Ph.D

Role: CONTACT

zhao4wei2@hotmail.com

86053188383308

Facility Contacts

Qiang Zhang

Role: primary

zq-9999@163.com

+8615562659602

Other Identifiers

SDU-2025-XM-002

Identifier Type: -

Identifier Source: org_study_id