Opioid-induced constipation
Conditions
Interventions
Treatment group:Shouhui Laxative Capsules: 0.35g per capsule, 0.7g per dose, three times daily, oral administration.
Control Group:Lactulose: 15ml per dose, twice daily, oral administration.
Sponsors
Jiangsu Provincial Research Institute of Chinese Medicine (Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 85 years old; 2) All cases are patients with histologically or cytologically confirmed malignant tumors and clearly diagnosed cancer pain; 3) All patients have a pain score of =4 on the visual analogue scale (VAS) and have been continuously using opioid medications for =1 week; 4) All patients meet the diagnostic criteria for opioid-induced constipation (OIC) according to Rome IV standards; 5) No consciousness disorders, able to cooperate with medical history collection; 6) Performance Status (PS) score =1, with an expected survival period >3 months; 7) Voluntarily participating in the clinical study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those with a history of constipation who still experience constipation prior to the use of opioid medications; 2) Individuals who have initiated or adjusted chemotherapy and/or radiotherapy regimens within the past week, making the cause of constipation difficult to ascertain; 3) Patients who have had adjustments to their NSAIDs regimen within the past week, and the investigator believes this may impact the assessment of gastrointestinal symptoms; 4) Patients who are unable to take oral medications; 5) Constipation due to organic/mechanical causes: suspected or confirmed conditions such as intestinal obstruction or paralytic ileus; 6) Constipation caused by non-opioid medications where the reversible underlying cause is uncontrolled (e.g., significant hypothyroidism, severe electrolyte imbalances, etc.); 7) Patients who have recently added or adjusted the dosage of medications that significantly affect bowel motility (e.g., anticholinergics, certain antidepressants/antipsychotics, etc.), and the investigator judges this may impact the evaluation of efficacy; 8) Severe organ dysfunction or unstable medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete spontaneous bowel movements; | — |
Secondary
| Measure | Time frame |
|---|---|
| Constipation Patients' Symptom Self-Assessment Scale;Constipation Patients' Quality of Life Assessment Scale; | — |
Countries
China
Contacts
Public ContactXing Haiyan
Jiangsu Provincial Research Institute of Chinese Medicine (Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine)
Outcome results
None listed