Patients with mild to moderate cancer pain
Conditions
Interventions
Trial group:Screening Period: The screening process will begin after the subjects sign the informed consent form. Subjects will undergo screening examinations, and those who meet the inclusion criteri
oral administration of 1 Baoxianzi capsule, once every 2 days, taken together with the first dose of Yunnan Baiyao capsules on those days).
Medication Cycle: Baseline analgesic plus study drug, dura
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gender is not restricted; age is between 18 and 70 years old; 2. Confirmed by past medical history, histopathology or cytology as cancer, accompanied by cancer-related pain; 3. ECOG score 6 months; 5. Patients with mild to moderate cancer-related pain that can be controlled by regular daily oral analgesics (i.e., NRS score >=1 and <=6); 6. Voluntary and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Has a history of chronic underlying diseases, has had poor control previously or is in the acute stage of the underlying disease upon admission; 2. Has severe diseases with severely impaired liver, kidney and liver function, coagulation function, with total bilirubin (TBIL) > 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5×ULN; serum creatinine (Scr) > 1.5×ULN or glomerular filtration rate (eGFR) < 30 ml/min/1.73m^2); 3. Has obvious gastrointestinal dysfunction symptoms within 14 days before the screening period, such as inability to swallow, uncontrollable nausea and vomiting, chronic diarrhea, intestinal obstruction, etc., or may affect the intake, transport or absorption of the drug; 4. Has known allergies to the study drug; 5. Pregnant or lactating, or unable to strictly follow contraception during the study period; 6. Has participated in other clinical trials within 3 months; 7. Has undergone radiotherapy to the pain area, etc.; 8. Has newly adopted a pain treatment method within 1 week before screening; 9. Has received new anti-tumor treatment that may affect pain, such as chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiotherapy or radiation therapy, within 2 weeks before screening; 10. Has undergone surgical procedures within 4 weeks before screening or plans to undergo surgical procedures during the study period, which may affect the assessment of pain status or cause study interruption; 11. Has communication disorders in language, cognitive deficits or mental illness; or patients with intracranial tumor metastasis and consciousness disorders; other causes of consciousness disorders; 12.Other conditions deemed unsuitable for participation in the study by the investigator, such as patients with poor compliance, or any conditions that may affect safety (such as drug dependence, alcohol abuse, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity NRS score;Safety indicators (including: vital signs, physical examination, electrocardiogram, blood routine, urine routine, coagulation function, liver and kidney function, adverse events, serious adverse events); | — |
Secondary
| Measure | Time frame |
|---|---|
| The score of the Brief Pain Assessment Scale (BPI);Sleep quality assessment;The dosage of emergency medication; | — |
Countries
China
Contacts
Public ContactXie Guanglun
Henan Cancer Hospital
Outcome results
None listed