Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shouhui Tongbian Capsules.
- Who it may be relevant to
- Registry conditions: Perioperative Period. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Postoperative intestinal function recovery time [Time frame: Throughout the study drug treatment period, about 2 weeks]
- Total duration of intestinal function recovery [Time frame: Throughout the study drug treatment period, about 2 weeks]
- Defecation trait score [Time frame: Throughout the study drug treatment period, about 2 weeks]
- Levels of inflammatory factors [Time frame: Throughout the study drug treatment period, about 2 weeks]
Secondary outcome measures (3)
- Adverse event rate [Time frame: Throughout the study drug treatment period, about 2 weeks]
- Comfort of intestinal preparation satisfaction questionnaire [Time frame: Throughout the study drug treatment period, about 2 weeks]
- Postoperative defecation satisfaction questionnaire [Time frame: Throughout the study drug treatment period, about 2 weeks]
Eligibility criteria
Inclusion criteria
- Aged 18-70 years, regardless of gender;
- ASA class I-III, elective surgery patients;
- Signed the informed consent form.
Exclusion criteria
- 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.
- 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.
- 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.
- 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.
- Other exclusions:
Participation in other clinical trials without passing the washout period; other situations where the investigator deems the subject unsuitable for the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shandong Public Health Clinical Center — Jinan
Identifiers
NCT: NCT07066059 · SDU-2025-XM-002