Sodium aescinate treatment for adult chronic low back pain
The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults
This trial tests whether oral sodium aescinate tablets can reduce pain and improve function in adults aged 18–65 with chronic low back pain lasting at least 12 weeks and a pain score above 4.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07339631 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 1 trial comparing oral sodium aescinate tablets to matched placebo in adults with non-specific chronic low back pain. Eligible participants (age 18–65, VAS >4, symptoms ≥12 weeks) are randomly assigned 1:1 and take 2 tablets twice daily for 6 weeks. Outcomes include pain intensity (VAS) at weeks 1, 3, and 6, disability scores (ODI), functional measures, and MRI measures of lumbar paraspinal muscle cross-sectional area and fat infiltration, with safety and adverse events monitored throughout. Follow-up visits occur at baseline, week 1, week 3, and week 6 for efficacy and safety assessments.
Who should consider this trial
Good fit: Adults 18–65 with non-specific chronic low back pain for at least 12 weeks and moderate to severe pain (VAS >4) who can take oral medication and attend in-person visits are ideal candidates.
Not a fit: People in an acute pain flare, those whose back pain is caused by infection, tumor, or other specific structural disease, patients outside the 18–65 age range, or those unable to attend visits are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, sodium aescinate could offer a new oral option to reduce pain and improve function and paraspinal muscle condition in people with chronic low back pain.
How similar studies have performed: There is limited clinical evidence for aescinate's anti-inflammatory effects, but oral sodium aescinate for chronic low back pain is relatively novel and not yet well established by prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Has moderate to severe pain, with a Visual Analog Scale (VAS) score \> 4 points. 3. Aged between 18 and 65 years old. 4. Has a clear understanding of the study content, good compliance, and high willingness to cooperate. 5. Has signed a written informed consent form voluntarily. Exclusion Criteria: 1. Is in the acute pain phase or acute exacerbation of chronic pain. 2. 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. 3. Has a history of allergy to sodium aescinate. 4. Suffers from systemic diseases or organ dysfunction. 5. Has participated in other clinical trials within 1 month before enrollment. 6. Has severe mental illness or other conditions that prevent cooperation with the study. 7. Is a pregnant or lactating woman, or a woman planning to become pregnant. 8. Has metal implants or other conditions that are not suitable for MRI examination. 9. Is considered by the researcher to have conditions that are unfavorable for completing the study course.
Where this trial is running
Xi'an, Shaanxi
- Xjing hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Bo Gao, MD, PhD
- Email: gaobofmmu@hotmail.com
- Phone: 029-84775507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.