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New treatment option for Low Back Pain
Official title Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults
ClinicalTrials.gov ID: NCT07339631
What this study is testing
What is Sodium Aescinate Tablets?
Sodium Aescinate Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for low back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meets the diagnostic criteria for chronic low back pain (cLBP) recommended by the Clinical Practice Guidelines for Chronic Low Back Pain in China...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.