Low Back Pain (LBP)NCT07126951
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
A study testing Ultrasound-guided Deep Pharmacopuncture Treatment and Korean medical treatment in people with Low Back Pain (LBP), run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This pilot randomized controlled clinical trial aims to evaluate the effectiveness and safety of ultrasound-guided deep pharmacopuncture therapy for acute low back pain (LBP) that occurs within seven days following a traffic accident. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Low Back Pain (LBP)
- What is being tested?
- Ultrasound-guided Deep Pharmacopuncture Treatment and Korean medical treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following:
- Adults aged 19 to 70 years.
- Patients who developed acute low back pain within 7 days after a traffic accident.
- Numeric Rating Scale (NRS) score of 5 or higher for low back pain.
- Radiological evidence of disc narrowing on lumbar spine X-ray.
- Complaints of radiating leg pain.
- Hospitalized for treatment related to the traffic accident.
- Able and willing to provide written informed consent voluntarily.
Who cannot join
- Participants will be excluded if they meet any of the following:
- Diagnosed with serious underlying conditions causing back pain (e.g., malignancy, spinal infection, inflammatory spondylitis).
- Presence of progressive or severe neurological deficits.
- Underwent lumbar surgery or procedures within the past 3 weeks.
- Back pain caused by non-spinal soft tissue disorders (e.g., fibromyalgia, rheumatoid arthritis, gout).
- Presence of chronic conditions that could interfere with study results (e.g., cardiovascular disease, renal disease, diabetic neuropathy, dementia, epilepsy).
Show all 13Show fewer
- Taking medications that could affect study outcomes (e.g., steroids, immunosuppressants, psychiatric drugs).
- Contraindicated or unsafe for acupuncture (e.g., bleeding disorders, anticoagulant therapy, severe diabetes with infection risk, severe cardiovascular conditions).
- Currently pregnant or planning pregnancy.
- Diagnosed with severe mental illness.
- Participation in other clinical trials (excluding observational studies).
- Unable to properly complete the informed consent form.
- Deemed inappropriate for participation by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Jaseng Hospital of Korean Medicine
Haeundae, Jaseng Hospital of Korean Medicine, 135-896
In-Hyuk Ha, phD, 3218-2249 Ext. 82, hanihata@jaseng.co.kr
About this study
Official title: A Pragmatic Randomized Controlled Pilot Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain Following Traffic Accidents
This pilot randomized controlled clinical trial aims to evaluate the effectiveness and safety of ultrasound-guided deep pharmacopuncture therapy for acute low back pain (LBP) that occurs within seven days following a traffic accident. While traditional Korean medicine-including acupuncture, herbal medicine, pharmacopuncture, and Chuna manual therapy-is commonly used for post-accident injuries, few studies have focused on deep pharmacopuncture administered under ultrasound guidance. This study will provide preliminary evidence to assess whether ultrasound-guided techniques offer added clinical benefits.
A total of 40 patients hospitalized at Jaseng Hospital of Korean Medicine in Haeundae, Korea, will be recruited and randomly assigned into two groups: the intervention group will receive integrative Korean medicine therapy plus ultrasound-guided pharmacopuncture, while the control group will receive integrative Korean medicine therapy alone. Both groups will undergo treatment during hospitalization, with the pharmacopuncture administered up to three times between hospital day 2 and day 4 in the intervention group. Baseline assessment will be done on day 2 before treatment, and the primary outcome will be measured on day 5. Follow-up assessments will be conducted at 2 and 4 weeks via telephone.
Read more
The primary outcome is the change in low back pain intensity as measured by the Numeric Rating Scale (NRS). Secondary outcomes include radiating pain, lumbar range of motion, Oswestry Disability Index (ODI), EQ-5D for quality of life, and the Patient Global Impression of Change (PGIC). Adverse events will also be monitored and classified according to established safety criteria.
This study will utilize both intention-to-treat (ITT) and per-protocol (PP) analyses, with linear mixed models and multiple imputation used to address missing data. Given the limited existing evidence on ultrasound-guided deep pharmacopuncture, this trial is designed to explore its feasibility and provide the groundwork for future large-scale trials.
Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.
Read the detailed description
This pragmatic, randomized, controlled pilot study investigates the comparative clinical effectiveness and safety of ultrasound-guided deep pharmacopuncture versus conventional integrative Korean medicine treatment for acute low back pain (LBP) occurring within 7 days after a traffic accident.
The study will enroll 40 hospitalized patients aged 19-70 who report moderate to severe acute LBP (NRS ≥5) and have disc narrowing visible on lumbar X-rays. Participants will be randomly assigned to one of two treatment arms (n=20 per group) using a block randomization procedure. The trial will proceed through a screening/enrollment phase, active inpatient treatment, and follow-up evaluations at 2 and 4 weeks post-enrollment.
The intervention group will receive a combination of standard integrative Korean medicine treatment and 1 to 3 sessions of ultrasound-guided deep pharmacopuncture between hospital day 2 and 4. The control group will receive standard care only, which includes acupuncture, non-ultrasound-guided pharmacopuncture, herbal medicine, and Chuna manual therapy.
The primary outcome is change in low back pain intensity (NRS) from baseline (Day 2 pre-treatment) to Day 5. Secondary outcomes include radiating pain, lumbar range of motion (ROM), functional status (Oswestry Disability Index), quality of life (EQ-5D-5L), and overall improvement (Patient Global Impression of Change). Adverse events will be systematically monitored and assessed.
The trial is designed to evaluate the feasibility, effect size estimation, and safety profile of ultrasound-guided pharmacopuncture in preparation for a larger-scale confirmatory trial. Analyses will follow both ITT and PP principles, with linear mixed models and imputation techniques for handling missing data.
The study adheres to ethical guidelines, including informed consent, privacy protection, and safety monitoring. Monitoring will be conducted by third parties per KCGP standards to ensure data quality and patient protection.
- Conditions
- Low Back Pain (LBP)
- Being tested
- Ultrasound-guided Deep Pharmacopuncture Treatment, Korean medical treatment
- Keywords
- pharmacopuncture, Ultrasound Guiding
- 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.
Ultrasound-guided Deep Pharmacopuncture TreatmentProcedure or surgery
Participants in this group will receive ultrasound-guided deep pharmacopuncture in addition to integrative Korean medicine treatment (acupuncture, herbal medicine, and Chuna therapy). The pharmacopuncture involves injecting 4 cc of herbal extract into deep lumbar tissues, targeting the posterior facet joint of the most symptomatic segment.
Using a real-time ultrasound-guided in-plane technique, the needle path and tip are visualized to ensure accurate and safe delivery. Treatment is administered once daily for up to 3 days (hospital Days 2-4).
This intervention differs from conventional methods by using ultrasound to guide precise, deep-tissue injection, enhancing both safety and treatment accuracy.
Korean medical treatmentProcedure or surgery
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Deep Pharmacopuncture Treatment | Experimental | Participants in this arm will receive integrative Korean medicine treatment combined with ultrasound-guided deep pharmacopuncture. The integrative treatment includes acupuncture, Chuna manual therapy (focused on cervical and lumbar regions), and oral herbal medicine administered during hospitalization.
In addition to these treatments, patients in this group will receive ultrasound-guided pharmacopuncture therapy once daily from Day 2 to Day 4 of hospitalization, for a maximum of three sessions. The pharmacopuncture procedure involves injecting 4 cc of herbal extract into deep lumbar tissue using a 26G sterile needle under real-time ultrasound guidance. The target site is selected based on lumbar spine X-ray findings (disc narrowing) and patient-reported radiating pain. The needle is inserted using an in-plane approach to visualize the needle tip reaching the posterior facet joint of the most symptomatic lumbar segment. Receives: Procedure: Ultrasound-guided Deep Pharmacopuncture Treatment; Procedure: Korean medical treatment |
| Korean medical treatment | Active comparator | The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: Korean medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back Pain intensity scale: Numeric Rating Scale(NRS)
The NRS is a numeric scale used to quantify the patient's subjective experience of pain. Patients rate their current low back pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
Measured: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Secondary outcomes (6)
Radiating pain intensity scale: Numeric Rating Scale(NRS)
This scale assesses the severity of radiating pain (e.g., pain extending to the legs). Patients rate their current radiating pain on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible radiating pain.
Measured: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Oswestry Disability Index (ODI)
The ODI is used to assess functional impairment due to low back pain. It consists of 10 items, each scored from 0 to 5, for a maximum score of 50. The final score is calculated as the average of the answered items and reflects the patient's level of disability in daily life.
Measured: Baseline(day2), day5, 2week after enrollment, 4week after enrollment
EuroQol-5D-5L (EQ-5D)
EQ-5D is a standardized tool for measuring health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels (1 = no problem, 5 = extreme problem). A Korean-specific value set will be applied to calculate utility scores.
Measured: Baseline(day2), day5, 2week after enrollment, 4week after enrollment
Physical Examination - Lumbar Active Range of Motion (AROM)
This measures the maximum range of motion in the lumbar spine that the patient can achieve without pain. Six movements are assessed: flexion, extension, left and right lateral bending, and left and right rotation. Measurements are taken using a goniometer. If the patient refuses due to severe pain, the result is recorded as 0 degrees.
Measured: Baseline(day2), day3, day4, day5
Patient Global Impression of Change (PGIC)
PGIC is a 7-point scale where patients rate their overall improvement following treatment, ranging from "very much improved" to "very much worse."
Measured: day5, 2week after enrollment, 4week after enrollment
Adverse Events (AE)
Any unfavorable and unintended sign, symptom, or disease temporally associated with the treatment will be recorded, regardless of a causal relationship. Events will be monitored and classified by severity (mild, moderate, severe) using Spilker's criteria, and by causality using a 6-point WHO-UMC scale.
Measured: Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain (LBP)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Pragmatic randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, phD, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126951
- Sponsor's protocol ID
- JS-CT-2025-08
- Status last verified
- Nov 2026
- First submitted
- 11 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Pilot Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain Following Traffic Accidents
- ClinicalTrials.gov ID
- NCT07126951
- Acronym / sponsor ID
- JS-CT-2025-08
- Conditions
- Low Back Pain (LBP)
- Keywords
- pharmacopuncture, Ultrasound Guiding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2025 (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.
This pilot randomized controlled clinical trial aims to evaluate the effectiveness and safety of ultrasound-guided deep pharmacopuncture therapy for acute low back pain (LBP) that occurs within seven days following a traffic accident. While traditional Korean medicine-including acupuncture, herbal medicine, pharmacopuncture, and Chuna manual therapy-is commonly used for post-accident injuries, few studies have focused on deep pharmacopuncture administered under ultrasound guidance. This study will provide preliminary evidence to assess whether ultrasound-guided techniques offer added clinical benefits.
A total of 40 patients hospitalized at Jaseng Hospital of Korean Medicine in Haeundae, Korea, will be recruited and randomly assigned into two groups: the intervention group will receive integrative Korean medicine therapy plus ultrasound-guided pharmacopuncture, while the control group will receive integrative Korean medicine therapy alone. Both groups will undergo treatment during hospitalization, with the pharmacopuncture administered up to three times between hospital day 2 and day 4 in the intervention group. Baseline assessment will be done on day 2 before treatment, and the primary outcome will be measured on day 5. Follow-up assessments will be conducted at 2 and 4 weeks via telephone.
The primary outcome is the change in low back pain intensity as measured by the Numeric Rating Scale (NRS). Secondary outcomes include radiating pain, lumbar range of motion, Oswestry Disability Index (ODI), EQ-5D for quality of life, and the Patient Global Impression of Change (PGIC). Adverse events will also be monitored and classified according to established safety criteria.
This study will utilize both intention-to-treat (ITT) and per-protocol (PP) analyses, with linear mixed models and multiple imputation used to address missing data. Given the limited existing evidence on ultrasound-guided deep pharmacopuncture, this trial is designed to explore its feasibility and provide the groundwork for future large-scale trials.
Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.
Detailed description
This pragmatic, randomized, controlled pilot study investigates the comparative clinical effectiveness and safety of ultrasound-guided deep pharmacopuncture versus conventional integrative Korean medicine treatment for acute low back pain (LBP) occurring within 7 days after a traffic accident.
The study will enroll 40 hospitalized patients aged 19-70 who report moderate to severe acute LBP (NRS ≥5) and have disc narrowing visible on lumbar X-rays. Participants will be randomly assigned to one of two treatment arms (n=20 per group) using a block randomization procedure. The trial will proceed through a screening/enrollment phase, active inpatient treatment, and follow-up evaluations at 2 and 4 weeks post-enrollment.
The intervention group will receive a combination of standard integrative Korean medicine treatment and 1 to 3 sessions of ultrasound-guided deep pharmacopuncture between hospital day 2 and 4. The control group will receive standard care only, which includes acupuncture, non-ultrasound-guided pharmacopuncture, herbal medicine, and Chuna manual therapy.
The primary outcome is change in low back pain intensity (NRS) from baseline (Day 2 pre-treatment) to Day 5. Secondary outcomes include radiating pain, lumbar range of motion (ROM), functional status (Oswestry Disability Index), quality of life (EQ-5D-5L), and overall improvement (Patient Global Impression of Change). Adverse events will be systematically monitored and assessed.
The trial is designed to evaluate the feasibility, effect size estimation, and safety profile of ultrasound-guided pharmacopuncture in preparation for a larger-scale confirmatory trial. Analyses will follow both ITT and PP principles, with linear mixed models and imputation techniques for handling missing data.
The study adheres to ethical guidelines, including informed consent, privacy protection, and safety monitoring. Monitoring will be conducted by third parties per KCGP standards to ensure data quality and patient protection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Deep Pharmacopuncture Treatment | Experimental | Procedure: Ultrasound-guided Deep Pharmacopuncture Treatment, Procedure: Korean medical treatmentParticipants in this arm will receive integrative Korean medicine treatment combined with ultrasound-guided deep pharmacopuncture. The integrative treatment includes acupuncture, Chuna manual therapy (focused on cervical and lumbar regions), and oral herbal medicine administered during hospitalization. In addition to these treatments, patients in this group will receive ultrasound-guided pharmacopuncture therapy once daily from Day 2 to Day 4 of hospitalization, for a maximum of three sessions. The pharmacopuncture procedure involves injecting 4 cc of herbal extract into deep lumbar tissue using a 26G sterile needle under real-time ultrasound guidance. The target site is selected based on lumbar spine X-ray findings (disc narrowing) and patient-reported radiating pain. The needle is inserted using an in-plane approach to visualize the needle tip reaching the posterior facet joint of the most symptomatic lumbar segment. |
| Korean medical treatment | Active comparator | Procedure: Korean medical treatmentThe control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 19 to 70 years.
- Patients who developed acute low back pain within 7 days after a traffic accident.
- Numeric Rating Scale (NRS) score of 5 or higher for low back pain.
- Radiological evidence of disc narrowing on lumbar spine X-ray.
- Complaints of radiating leg pain.
Key exclusion criteria (13 listed)
- Diagnosed with serious underlying conditions causing back pain (e.g., malignancy, spinal infection, inflammatory spondylitis).
- Presence of progressive or severe neurological deficits.
- Underwent lumbar surgery or procedures within the past 3 weeks.
- Back pain caused by non-spinal soft tissue disorders (e.g., fibromyalgia, rheumatoid arthritis, gout).
- Presence of chronic conditions that could interfere with study results (e.g., cardiovascular disease, renal disease, diabetic neuropathy, dementia, epilepsy).
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 |
|---|---|---|
| Ultrasound-guided Deep Pharmacopuncture TreatmentParticipants in this group will receive ultrasound-guided deep pharmacopuncture in addition to integrative Korean medicine treatment (acupuncture, herbal medicine, and Chuna therapy). The pharmacopuncture involves injecting 4 cc of herbal extract into deep lumbar tissues, targeting the posterior facet joint of the most symptomatic segment. Using a real-time ultrasound-guided in-plane technique, the needle path and tip are visualized to ensure accurate and safe delivery. Treatment is administered once daily for up to 3 days (hospital Days 2-4). This intervention differs from conventional methods by using ultrasound to guide precise, deep-tissue injection, enhancing both safety and treatment accuracy. | Procedure or surgery | Ultrasound-guided Deep Pharmacopuncture Treatment |
| Korean medical treatmentacupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine | Procedure or surgery | Korean medical treatment, Ultrasound-guided Deep Pharmacopuncture Treatment |
Primary outcome
Low back Pain intensity scale: Numeric Rating Scale(NRS)
Time frame: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
The NRS is a numeric scale used to quantify the patient's subjective experience of pain. Patients rate their current low back pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
6 secondary outcomes
Radiating pain intensity scale: Numeric Rating Scale(NRS)
Time frame: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Oswestry Disability Index (ODI)
Time frame: Baseline(day2), day5, 2week after enrollment, 4week after enrollment
EuroQol-5D-5L (EQ-5D)
Time frame: Baseline(day2), day5, 2week after enrollment, 4week after enrollment
Physical Examination - Lumbar Active Range of Motion (AROM)
Time frame: Baseline(day2), day3, day4, day5
Patient Global Impression of Change (PGIC)
Time frame: day5, 2week after enrollment, 4week after enrollment
Adverse Events (AE)
Time frame: Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
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 5 Nov 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.
In-Hyuk Ha, phD principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Deep Pharmacopuncture Treatment and Korean medical treatment in people with Low Back Pain (LBP), run by Jaseng Medical Foundation at 1 site in South Korea.
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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 5 Nov 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 In-Hyuk Ha, phD (02-2222-2740, hanitata@jaseng.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back Pain intensity scale: Numeric Rating Scale(NRS) (time frame: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment). 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 5 Nov 2026.