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

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Postoperative intestinal function recovery time [Срок оценки: Throughout the study drug treatment period, about 2 weeks]
• Total duration of intestinal function recovery [Срок оценки: Throughout the study drug treatment period, about 2 weeks]
• Defecation trait score [Срок оценки: Throughout the study drug treatment period, about 2 weeks]
• Levels of inflammatory factors [Срок оценки: Throughout the study drug treatment period, about 2 weeks]

Вторичные конечные точки (3)

• Adverse event rate [Срок оценки: Throughout the study drug treatment period, about 2 weeks]
• Comfort of intestinal preparation satisfaction questionnaire [Срок оценки: Throughout the study drug treatment period, about 2 weeks]
• Postoperative defecation satisfaction questionnaire [Срок оценки: Throughout the study drug treatment period, about 2 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong Public Health Clinical Center — Цзинань

Идентификаторы

NCT: NCT07066059 · SDU-2025-XM-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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