Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults

Sponsor
Xijing Hospital
Study ID
NCT07339631
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sodium Aescinate Tablets — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 14, 2026
Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    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.
  • Experimental: Sodium Aescinate Tablets
    Participants in this arm will receive oral sodium aescinate tablets.

Primary Outcome Measure

Pain Intensity Assessed by Visual Analog Scale (VAS) Score [ Time Frame: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment ]

Central Contacts

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