Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults
NCT ID: NCT07339631
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2026-01-01
2029-09-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
Sodium Aescinate Tablets
Participants in this arm will receive oral sodium aescinate tablets.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Bo Gao, MD
principal investigator
Locations
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Xjing hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Other Identifiers
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KY20252323
Identifier Type: -
Identifier Source: org_study_id
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