Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults
The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults
Xijing Hospital
40 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Meets the diagnostic criteria for chronic low back pain (cLBP) recommended by the Clinical Practice Guidelines for Chronic Low Back Pain in China (2024 Edition): the course of disease lasts at least 12 weeks, with pain occurring in the region below the lower costal margin, above the gluteal crease (horizontal gluteal fold), and between the midaxillary lines on both sides, which may be accompanied by pain in one or both lower extremities.
- Has moderate to severe pain, with a Visual Analog Scale (VAS) score \> 4 points.
- Aged between 18 and 65 years old.
- Has a clear understanding of the study content, good compliance, and high willingness to cooperate.
- Has signed a written informed consent form voluntarily.
Exclusion Criteria9
- Is in the acute pain phase or acute exacerbation of chronic pain.
- Has low back pain caused by other reasons such as infectious diseases or tumors, including but not limited to spinal tumors, spinal tuberculosis, spinal cord infections, etc.
- Has a history of allergy to sodium aescinate.
- Suffers from systemic diseases or organ dysfunction.
- Has participated in other clinical trials within 1 month before enrollment.
- Has severe mental illness or other conditions that prevent cooperation with the study.
- Is a pregnant or lactating woman, or a woman planning to become pregnant.
- Has metal implants or other conditions that are not suitable for MRI examination.
- Is considered by the researcher to have conditions that are unfavorable for completing the study course.
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Interventions
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.
Locations(1)
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NCT07339631