lumbar spinal stenosis
Conditions
Interventions
Experimental group:Limeprost tablets+ mecobalamin Tablets
control group:Iricoxib tablets+ mecobalamin Tablets
Sponsors
Peking University Shougang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years old, gender unlimited; 2) Patients with lumbar spinal stenosis confirmed by clinical and imaging diagnosis (history, physical examination and imaging examination); 3) No indications for surgery; 4) Sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy or intolerance to limaprost or imrecoxib, alpha cyclodextrin, and other pharmaceutical excipients; 2) Evidence or history of hemorrhagic disease, bleeding tendency, bleeding constitution or coagulation disorder; 3) Congestive heart failure, unstable angina pectoris (symptoms of angina pectoris at rest), or myocardial infarction of greater severity than New York Heart Association Class II; 4) Patients with active gastrointestinal ulcers/bleeding or recurrent ulcers/bleeding in the past; 5) Ventricular arrhythmias requiring treatment with antiarrhythmic drugs or uncontrolled hypertension (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); 6) Women who are pregnant, lactating or planning to become pregnant during the trial, as well as male and female patients with reproductive potential who are unwilling to use effective contraceptive methods or abstain from sex during the study; 7) Any disease that is unstable or may harm the safety and compliance of patients; 8) The liver and kidney function indexes of the patients were abnormal within 1 month before enrollment, that is, the results of any of the following laboratory tests were as follows: a) Aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN) b) Alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) c) Serum creatinine (Cr) >3 times the upper limit of normal (ULN); 9) Participated in other clinical trials within 3 months before enrollment; 10) Other diseases or conditions deemed unsuitable for participation in the study by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the improvement rate of JOA score after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| the improvement rate of JOA score after 4weeks of treatment;The VAS score change and rate of lower limb numbness after 4 and 8 weeks of treatment;Incidence of treatment adverse events (TEAE);Treatment cost; | — |
Countries
China
Contacts
Public ContactGuan Zhenpeng
Peking University Shougang Hospital
Outcome results
None listed