The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain Intensity Assessed by Visual Analog Scale (VAS) Score
研究概览
简要总结
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.
详细描述
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:
- Does oral sodium aescinate tablets reduce pain intensity (measured by VAS score) in adult LBP patients at 1, 3, and 6 weeks after treatment?
- 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:
- Undergo screening (medical history review, physical examination, and relevant tests) to confirm eligibility and sign an informed consent form.
- Be randomly assigned to either the experimental or control group in a 1:1 ratio.
- Take 2 tablets of the assigned study medication (sodium aescinate tablets or placebo) twice daily for 6 consecutive weeks.
- 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).
- Undergo lumbar MRI scans at baseline and week 6 to measure paraspinal muscle cross-sectional area and fat infiltration rate.
- Report any adverse events experienced during the 6-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
Sodium Aescinate Tablets
Participants in this arm will receive oral sodium aescinate tablets.
干预措施: Sodium Aescinate Tablets (Drug)
结局指标
主要结局
Pain Intensity Assessed by Visual Analog Scale (VAS) Score
时间窗: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment
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.
次要结局
- 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)
研究者
Bo Gao, MD
principal investigator
Xijing Hospital