Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial

Exclusion Criteria21

• 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.