Sodium aescinate treatment for adult chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xjing hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Bo Gao, MD, PhD
• Email: gaobofmmu@hotmail.com
• Phone: 029-84775507

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bone marrow concentrate injection added to lumbar microdiscectomy

  This trial tests whether adding a bone marrow aspirate concentrate injection during lumbar microdiscectomy helps adults recover better than surgery alone.

  Recruiting Weill Medical College of Cornell University · Manhattan, New York · NCT07386548

• TENS to relieve myofascial low back pain in adults.

  This study will try TENS five times a week for four weeks to see if it reduces pain and improves function in adults with myofascial low back pain.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07368920

• A novel multi angular isometric lumbar exercise for chronic low back pain

  This trial tests MAILE, a new lumbar exercise method, to see if it helps adults with nonspecific chronic low back pain more than standard lumbar stabilization and core exercises.

  Recruiting Hamad Medical Corporation · Doha · NCT07908693

• Pain catastrophizing, fear of movement, and activity in postmenopausal women with chronic low back pain

  This observational study looks at how negative pain thoughts and fear of moving relate to how active postmenopausal women with long‑standing low back pain are.

  Recruiting Istanbul Medipol University Hospital · Istanbul, Istanbul · NCT07856498

• Analgesia boost from adding a sacral submultifidus block to SIJ injection

  This study tests whether adding a sacral submultifidus block to a standard image-guided sacroiliac joint injection provides better pain relief and function for adults with chronic SIJ‑related pain.

  Recruiting Fayoum University Hospital · Al Fayyum · NCT07814729

• Telerehabilitation after spine surgery

  This trial tests different ways of delivering post-operative instructions to people who had spinal decompression surgery to see how it affects recovery and healthcare use.

  Recruiting Kuopio University Hospital · Kuopio · NCT07795697

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.