Low back pain
Conditions
Interventions
Saponin Sodium Tablets Intervention Group:Take two tablets of oral sodium aescinate (30 mg per tablet) twice daily for a total of six weeks
Placebo group:Oral placebo tablets, 2 tablets (30 mg/tablet), twice daily, for a total of 6 weeks
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria recommended in the Chinese Guidelines for the Diagnosis and Treatment of Chronic Low Back Pain (2024 Edition) : a pain syndrome lasting at least 12 weeks, occurring in the region below the lower costal margin and above the gluteal crease (horizontal gluteal fold), between the mid-axillary lines bilaterally, often accompanied by pain in one or both lower limbs; 2.Meets clinical criteria for mechanical low back pain: pain exacerbated by postural changes, bending, weight-bearing, prolonged sitting/standing, or other increased mechanical loads, and relieved by rest; 3. Mild pain, Visual Analogue Scale (VAS) < 4 points; 4. Patient age between 18 and 65 years; 5. Patient fully understands study details, demonstrates good compliance, and high level of cooperation; 6. Informed consent form signed.
Exclusion criteria
Exclusion criteria: 1. Patients experiencing acute pain or acute exacerbation of chronic pain; 2. Patients with confirmed non-mechanical low back pain, including but not limited to spinal tumors, spinal tuberculosis, spinal cord infections, etc.; 3. Individuals with a history of sodium aescinate allergy; 4. Patients with systemic diseases or organ dysfunction; 5. Participants who have enrolled in other clinical trials within one month prior to enrollment; 6. Patients with severe psychiatric disorders or other conditions precluding cooperation; 7. Pregnant or lactating women, or women planning pregnancy; 8. Patients with metal implants or other conditions contraindicating MRI examination; 9. Patients deemed by the investigator to have circumstances unfavorable for completing the trial course .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale,VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OswestryDisability Index, ODI ;Japanese Orthopaedic Association Scores;Health condition;Lumbar Spine MRI indicators; | — |
Countries
China
Contacts
Public ContactGao bo
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed