NCT07304076 Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
| NCT ID | NCT07304076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jaseng Medical Foundation |
| Condition | Chronic Low Back Pain (CLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2029-11-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2025-12-17 with a primary completion date of 2029-11-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multicenter randomized controlled trial
Eligibility Criteria
Inclusion Criteria: * Adults aged 19 to 69 years at the time of signing the informed consent. * Individuals who have experienced low back pain for ≥6 months, presenting with either continuous or intermittent symptoms. * Participants with a Numeric Rating Scale (NRS) score ≥ 5 for low back pain at screening. * Individuals who fully understand the clinical trial procedures and voluntarily agree to participate by providing written informed consent. Exclusion Criteria: * Patients diagnosed with serious underlying conditions that may cause low back pain, such as spinal metastasis of malignancy, acute vertebral fracture, or spinal dislocation. * Patients with progressive neurological deficits or those presenting with severe neurological symptoms. * Patients whose pain originates from non-spinal soft tissue disorders, including tumors, fibromyalgia, rheumatoid arthritis, or gout. * Individuals with other chronic medical conditions that may interfere with treatment response or interpretation of study outcomes, such as stroke, myocardial infarction, chronic kidney disease, diabetic neuropathy, dementia, or epilepsy. * Individuals currently taking corticosteroids, immunosuppressants, psychiatric medications, or any other drugs that may influence study results.\* * Patients for whom pharmacopuncture is inappropriate or unsafe, including those with bleeding disorders or those receiving anticoagulant therapy. * Individuals who have taken analgesic medications such as NSAIDs or received pharmacopuncture treatment within the past 1 week. * Women of childbearing potential who are unwilling to use medically acceptable contraception (e.g., surgical sterilization, intrauterine device, condom or diaphragm use, injectable or implantable contraceptives) throughout the study period. * Pregnant or breastfeeding women. * Individuals with a history of hypersensitivity or allergic reactions to Hominis placenta pharmacopuncture (JHG002). * Patients with uncontrolled diabetes mellitus (fasting blood glucose ≥ 180 mg/dL). * Individuals whose AST (GOT) or ALT (GPT) levels are ≥ 2 times the upper limit of the normal range at the study site. * Individuals whose serum creatinine levels are ≥ 2 times the upper limit of the normal range at the study site. * Patients suspected of having an underlying organic disease. * Patients with moderate systemic complications involving organs other than the heart, liver, or kidneys. * Patients with psychogenic disorders. * Individuals with an implanted cardiac pacemaker. * Patients with inflammation, infection, wounds, or other lesions at the planned pharmacopuncture sites that would prevent safe administration. * Patients within 3 months after lumbar spine surgery. * Individuals who have participated in another clinical trial within the past 1 month, or who plan to participate in another clinical trial-including follow-up periods-within 6 months from the screening date. * Any individual deemed unsuitable for participation in this study by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07304076 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 70 Years, studying Chronic Low Back Pain (CLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304076 currently recruiting?
Yes, NCT07304076 is actively recruiting participants. Contact the research team at hanihata@gmail.com for enrollment information.
Where is the NCT07304076 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea, Bucheon-si, South Korea, Seongnam, South Korea.
Who is sponsoring the NCT07304076 clinical trial?
NCT07304076 is sponsored by Jaseng Medical Foundation. The trial plans to enroll 96 participants.