Post-operative Gastrointestinal Dysfunction
Conditions
Interventions
Experimental group:the Shouhui Tongbian Capsule
Placebo group:the Shouhui Tongbian Capsule simulator
Sponsors
The Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Male or female aged 40 to 80 years old (including the boundary value); 2) Patients who plan to undergo orthopedic surgery under general anesthesia or intramural anesthesia (including spinal surgery, hip/knee surgery, and fracture surgery) and are judged by the investigators to be hospitalized for at least 4 days after surgery (including the day of surgery). 3) The subjects voluntarily join the study, and can understand the study requirements, sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Allergic to related ingredients or excipients of the Shouhui Tongbian Capsule; 2) Patients with a history of liver injury caused by polygonum multiflorum or polygonum multiflorum preparations; 3) Patients with abnormal liver function indicated by laboratory examination during the screening period: AST or ALT > 2.5 times the upper limit of the normal value; 4) Inability to take the study drug orally or eat solid food; 5) Emergency surgery is required; 6) The operation requires peritoneal approach or may stimulate the peritoneum; 7) Patients with a history of intestinal obstruction; 8) Patients who have been diagnosed with organic intestinal diseases and are judged by researchers to be likely to affect the evaluation of the effect, such as intestinal tuberculosis, inflammatory bowel disease, colon tumor, etc.; 9) After assessment, the physical status classification system (ASA) exceeds ASA III; 10) Patients with malignancy; 11) Patients with rheumatic diseases accompanied by gastrointestinal reactions; 12) Patients with long-term use of opioids, defined by the American Pain Society as daily or nearly daily use of opioids for at least 90 days; 13) Patients with serious primary diseases including cardiovascular and cerebrovascular, liver, kidney, lung, and hematopoietic system that are judged by the researchers unfit to be included in this study; 14) Patients Combined with mental and neurological disorders, unable to express their wishes correctly; 15) Chinese and Western drugs that have an effect on gastrointestinal motility, including but not limited to dopamine receptor antagonists, 5-HT4 receptor agonists, opioid receptor agonists, opioid receptor antagonists, motilin receptor agonists, cholecystokinin (CCK) receptor antagonists, etc., have been taken within 7 days before screening; 16) Participants in clinical trials of other interventional drugs or medical devices within 1 month before screening; 17) Pregnant or lactating women, or women who have a pregnancy plan from the enrollment to 3 months after the end of the trial; 18) Patients determined by the investigators not suitable for inclusion in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of the first Spontaneous Bowel Movement (SBM) after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anal exhaust time; | — |
Countries
China
Contacts
Public ContactTang Peifu
The Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army
Outcome results
None listed