NCT07339631

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. Does oral sodium aescinate tablets reduce pain intensity (measured by VAS score) in adult LBP patients at 1, 3, and 6 weeks after treatment? 2. Is oral sodium aescinate tablets safe for adult LBP patients, with an acceptable adverse event profile during the 6-week treatment period? 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: 1. Undergo screening (medical history review, physical examination, and relevant tests) to confirm eligibility and sign an informed consent form. 2. Be randomly assigned to either the experimental or control group in a 1:1 ratio. 3. Take 2 tablets of the assigned study medication (sodium aescinate tablets or placebo) twice daily for 6 consecutive weeks. 4. Complete follow-up visits at baseline (week 0), week 1, week 3, and week 6 for efficacy assessments (VAS, Oswestry Disability Index \[ODI\], Japanese Orthopaedic Association \[JOA\] score, 36-Item Short Form Health Survey \[SF-36\] score). 5. Undergo lumbar MRI scans at baseline and week 6 to measure paraspinal muscle cross-sectional area and fat infiltration rate. 6. Report any adverse events experienced during the 6-week treatment period.

Conditions

• Low Back Pain
• Paraspinal Muscle
• CLBP - Chronic Low Back Pain
• Non-specific Chronic Low Back Pain

Interventions

Type	Name	Description
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.
DRUG	Placebo	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2026-01-14
• Last updated: 2026-03-20

Locations

1 site across 1 country: China