Herpes zoster
Conditions
Interventions
Experimental group:Intramuscular injection of cobopeptide, oral pregabalin simulator
Control group:Intramuscular injection of cobopeptide injection simulator, oral pregabalin capsule
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent voluntarily, be willing and able to take and inject drugs and accurately assess their own state, including pain intensity, quality of life, adverse reactions and events; 2. The patient was diagnosed with herpes zoster with typical clinical manifestations, and was evaluated by neuropathic Pain Scale (ID-pain scale) with neuralgia symptoms; 3, age 50-70 years old (including the cut-off value), male and female; 4. NRS score =4 points at 11 points (within 24 hours before randomization); 5. The onset of herpes zoster nerve pain does not exceed 30 days; 6. Creatinine clearance Crcl=60 mL/min; 7. Did not receive analgesic drugs before screening; 8. Willing and able to comply with the prohibitions and restrictions stipulated in the research protocol.
Exclusion criteria
Exclusion criteria: 1. In the investigator's judgment, subjects have clinically significant medical conditions that may affect the efficacy and safety assessment, such as severely unstable heart, blood vessels, lungs, gastrointestinal tract, and internal components Secretory, neurological, psychiatric disorders (disorientation, impaired memory or inability to accurately report) or metabolic disorders; 2. Patients who are known to be allergic to any ingredient in the study drug, allergic constitution, glaucoma and high fever; 3. Moderate or severe liver function impairment, or the subject's laboratory examination results showed liver insufficiency (AST, ALT=ULN×2.5) during pregnancy and lactation; 4. Impaired renal function, defined as creatinine clearance < 60ml/min calculated using the "Cockcroft-Gault formula"; 5. Laboratory test results are higher or lower than the normal range, which may affect the safety of the subjects according to the researchers; 6. Patients with malignant tumors, immune system diseases, and long history of epilepsy; 7. Participants in other clinical trials within 3 months; 8. History of drug abuse, alcoholism and drug abuse; 9. Use combination drugs and/or treatment prohibited in the program; 10. Participants judged by the researchers to be unfit for this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief (NRS score decline); | — |
Secondary
| Measure | Time frame |
|---|---|
| PHN incidence;Quality of Life: Concise Pain Assessment Scale Questionnaire (BPI); Pittsburgh Sleep Quality Index (PSQI);Pain response rate (percentage of patients with a 30-50% reduction in NRS score from baseline);Pain relief: At day 7±1, at day 11±1, 14±1, 22±1, and at week 12 ±3, NRS score compared to baseline;Patient's overall impression of change (PGIC) and clinical overall impression of change (CGIC);Duration of analgesic effect; | — |
Countries
China
Contacts
Public ContactXinghua Gao
The First Hospital of China Medical University
Outcome results
None listed