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

Официальное название

The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults

Обзор

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.

Подробное описание

The goal of this clinical trial is to evaluate the efficacy and safety of oral sodium aescinate in improving symptoms and function in adult participants aged 18-65 years with low back pain (LBP) lasting at least 12 weeks and a Visual Analog Scale (VAS) score \> 4 points. The main questions it aims to answer are:

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.

Вмешательства

• Препарат 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, d
• Препарат 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 record

Первичные конечные точки

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

Вторичные конечные точки (5)

• Disability Severity Assessed by Oswestry Disability Index (ODI) Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment]
• Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI [Срок оценки: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xjing hospital — Сиань

Идентификаторы

NCT: NCT07339631 · KY20252323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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