Low Back PainPhase 1NCT07339631
Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults
A Phase 1 study testing Sodium Aescinate Tablets in people with Low Back Pain and Paraspinal Muscle, run by Xijing Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Paraspinal Muscle, CLBP - Chronic Low Back Pain
- What is being tested?
- Sodium Aescinate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 1 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Paraspinal Muscle, CLBP - Chronic Low Back Pain, Non-specific Chronic Low Back Pain
- Being tested
- Sodium Aescinate Tablets, Placebo
- Keywords
- low back pain, sodium aescinate tablets, double-blind randomized controlled trial, CLBP - Chronic Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Aescinate TabletsDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Sodium Aescinate Tablets | Experimental | Participants in this arm will receive oral sodium aescinate tablets. Receives: Drug: Sodium Aescinate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessed by Visual Analog Scale (VAS) Score
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.
Measured: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment
Secondary outcomes (5)
Disability Severity Assessed by Oswestry Disability Index (ODI) Score
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a widely used questionnaire with a total score range of 0 to 50 points. Higher scores indicate greater disability in activities of daily living. This outcome measure evaluates changes in functional disability in cLBP patients after treatment.
Measured: 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
Lumbar spine function will be evaluated using the Japanese Orthopaedic Association (JOA) score, which ranges from 0 to 29 points. Lower scores indicate more severe functional impairment. This outcome measure assesses changes in lumbar spine function following treatment.
Measured: 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
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The total score ranges from 0 to 100 points, with higher scores indicating better overall health status. This outcome measure evaluates changes in overall quality of life in cLBP patients following treatment.
Measured: 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
Lumbar MRI will be used to measure the cross-sectional area of paraspinal muscles as an objective indicator of muscle mass. This outcome measure evaluates changes in paraspinal muscle size following treatment with sodium aescinate tablets.
Measured: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment
Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI
Lumbar MRI will be used to assess the fat infiltration rate of paraspinal muscles as an indicator of muscle quality. This outcome measure evaluates changes in paraspinal muscle composition following treatment.
Measured: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective parallel-group study. Participants are randomly assigned to either the experimental group (sodium aescinate tablets) or the placebo group in a 1:1 ratio. Both groups receive the assigned intervention for 6 consecutive weeks, with no crossover between groups during the study period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Gao, MD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339631
- Sponsor's protocol ID
- KY20252323
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults
- ClinicalTrials.gov ID
- NCT07339631
- Acronym / sponsor ID
- KY20252323
- Conditions
- Low Back Pain, Paraspinal Muscle, CLBP - Chronic Low Back Pain, Non-specific Chronic Low Back Pain
- Keywords
- low back pain, sodium aescinate tablets, double-blind randomized controlled trial, CLBP - Chronic Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, prospective parallel-group study. Participants are randomly assigned to either the experimental group (sodium aescinate tablets) or the placebo group in a 1:1 ratio. Both groups receive the assigned intervention for 6 consecutive weeks, with no crossover between groups during the study period.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Sodium Aescinate Tablets | Experimental | Drug: Sodium Aescinate TabletsParticipants in this arm will receive oral sodium aescinate tablets. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Aescinate TabletsThis 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. | Drug | Sodium Aescinate Tablets |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
Pain Intensity Assessed by Visual Analog Scale (VAS) Score
Time frame: 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.
5 secondary outcomes
Disability Severity Assessed by Oswestry Disability Index (ODI) Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment
Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI
Time frame: Baseline (Day 0, pre-intervention) and Week 6 after the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Aescinate Tablets in people with Low Back Pain and Paraspinal Muscle, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Gao, MD, PhD (029-84775507, gaobofmmu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analog Scale (VAS) Score (time frame: Baseline (Day 0, pre-intervention), Week 1, Week 3, and Week 6 after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.