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

NCT07339631 | Recruiting Phase 1

• 1 other identifier: KY20252323
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

low back pain; sodium aescinate tablets; double-blind randomized controlled trial; CLBP - Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment

Secondary Outcomes (5)

• Disability Severity Assessed by Oswestry Disability Index (ODI) Score

  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

  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

  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

  Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment

• Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI

  Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment

Other Outcomes (1)

• Incidence of Adverse Events During Treatment

  Within 6 weeks after the start of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Sodium Aescinate Tablets

EXPERIMENTAL

Participants in this arm will receive oral sodium aescinate tablets.

Drug: Sodium Aescinate Tablets

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.

Sodium Aescinate Tablets

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xjing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

sodium aescinate

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bo Gao, MD, PhD

CONTACT

029-84775507; gaobofmmu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A dedicated researcher (not involved in data collection, analysis, or follow-up) prepares and distributes the study medications (sodium aescinate tablets and matching placebo), which are identical in appearance, dosage form, and administration route to ensure masking. Emergency unblinding is permitted for safety reasons, with documentation of the date and reason required within 48 hours.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This is a single-center, prospective parallel-group study. Participants are randomly assigned to either the experimental group (sodium aescinate tablets) or the placebo group in a 1:1 ratio. Both groups receive the assigned intervention for 6 consecutive weeks, with no crossover between groups during the study period.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 14, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)