A Phase 1 interventional study of Sodium Aescinate Tablets and Placebo in Low Back Pain, Paraspinal Muscle and CLBP - Chronic Low Back Pain, sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Xijing Hospital · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to assess the clinical efficacy and safety of sodium aescinate in treating low back pain (LBP) in adult participants.
The goal of this clinical trial is to evaluate the efficacy and safety of oral sodium aescinate in improving symptoms and function in adult participants aged 18-65 years with low back pain (LBP) lasting at least 12 weeks and a Visual Analog Scale (VAS) score > 4 points. The main questions it aims to answer are:
Researchers will compare participants receiving sodium aescinate (experimental group) to those receiving a placebo (control group) to see if the experimental intervention results in significant improvements in pain, disability, functional status, and lumbar paraspinal muscle conditions (cross-sectional area and fat infiltration rate) compared to the placebo.
Participants will:
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
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Exclusion Criteria:
Participants in this arm will receive oral sodium aescinate mimetic tablets (placebo), which are identical to the experimental drug (sodium aescinate tablets) in appearance, dosage form, color, and taste.
Drug: Placebo
Participants in this arm will receive oral sodium aescinate tablets.
Drug: Sodium Aescinate Tablets
This intervention is an oral sodium aescinate tablets. Each tablet contains 30mg of sodium aescinate as the active ingredient. Eligible participants will take 2 tablets per dose, twice daily (bid), for a continuous 6-week treatment period. The drug is provided by Shandong Luye Pharmaceutical Co., Ltd. and is administered in a double-blind manner, with the placebo control having identical appearance, dosage form, and administration route to ensure masking. The intervention aims to improve pain, disability, and functional status in adult patients with chronic low back pain by exerting anti-inflammatory, detumescent, and microcirculation-improving effects.
The intervention dosage is 2 tablets (30mg/tablet) per administration, twice daily (bid), for a continuous 6-week treatment period. During the study, participants will complete follow-up visits at baseline (week 0), week 1, week 3, and week 6 for efficacy assessments (VAS, ODI, JOA, SF-36 scores) and undergo lumbar MRI scans at baseline and week 6 to measure paraspinal muscle cross-sectional area and fat infiltration rate. All adverse events experienced during the treatment period will be recorded in detail.
Pain Intensity Assessed by Visual Analog Scale (VAS) Score
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated tool with a score range from 0 to 10 points. A score of 0 represents no pain, and a score of 10 represents the most severe pain imaginable. This outcome measure evaluates changes in pain intensity in adults with chronic low back pain (cLBP) following treatment with oral sodium aescinate tablets.
Time frame: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment
Disability Severity Assessed by Oswestry Disability Index (ODI) Score
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a widely used questionnaire with a total score range of 0 to 50 points. Higher scores indicate greater disability in activities of daily living. This outcome measure evaluates changes in functional disability in cLBP patients after treatment.
Time frame: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment
Lumbar Functional Status Assessed by Japanese Orthopaedic Association (JOA) Score
Lumbar spine function will be evaluated using the Japanese Orthopaedic Association (JOA) score, which ranges from 0 to 29 points. Lower scores indicate more severe functional impairment. This outcome measure assesses changes in lumbar spine function following treatment.
Time frame: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment
Health-Related Quality of Life Assessed by SF-36 Total Score
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The total score ranges from 0 to 100 points, with higher scores indicating better overall health status. This outcome measure evaluates changes in overall quality of life in cLBP patients following treatment.
Time frame: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment
Lumbar Paraspinal Muscle Cross-Sectional Area Assessed by MRI
Lumbar MRI will be used to measure the cross-sectional area of paraspinal muscles as an objective indicator of muscle mass. This outcome measure evaluates changes in paraspinal muscle size following treatment with sodium aescinate tablets.
Time frame: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment
Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI
Lumbar MRI will be used to assess the fat infiltration rate of paraspinal muscles as an indicator of muscle quality. This outcome measure evaluates changes in paraspinal muscle composition following treatment.
Time frame: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment
Incidence of Adverse Events During Treatment
All adverse events (AEs) occurring during the 6-week treatment period will be recorded. For each AE, the type, severity, duration, and relationship to the study drug will be documented to evaluate the safety of oral sodium aescinate tablets.
Time frame: Within 6 weeks after the start of treatment
Plan to share: No
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