None listed
Conditions
Interventions
Drug, Medical Device : JHG002 pharmacopuncture is a purified Hominis placenta extract formulated for injection at acupuncture points. In Korean medicine, Hominis placenta has traditionally been used t
Sponsors
Bucheon Jaseng Hospital of Korean Medicine, Jaseng Medical Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who have experienced low back pain for =6 months, presenting with either continuous or intermittent symptoms. 2. Participants with a Numeric Rating Scale (NRS) score = 5 for low back pain at screening. 3. Adults aged 19 to 69 years at the time of signing the informed consent. 4. Individuals who fully understand the clinical trial procedures and voluntarily agree to participate by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with serious underlying conditions that may cause low back pain, such as spinal metastasis of malignancy, acute vertebral fracture, or spinal dislocation. 2. Patients with progressive neurological deficits or those presenting with severe neurological symptoms. 3. Patients whose pain originates from non-spinal soft tissue disorders, including tumors, fibromyalgia, rheumatoid arthritis, or gout. 4. 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. 5. Individuals currently taking corticosteroids, immunosuppressants, psychiatric medications, or any other drugs that may influence study results.* 6. Patients for whom pharmacopuncture is inappropriate or unsafe, including those with bleeding disorders or those receiving anticoagulant therapy. 7. Individuals who have taken analgesic medications such as NSAIDs or received pharmacopuncture treatment within the past 1 week. 8. 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. 9. Pregnant or breastfeeding women. 10. Individuals with a history of hypersensitivity or allergic reactions to Hominis placenta pharmacopuncture (JHG002). 11. Patients with uncontrolled diabetes mellitus (fasting blood glucose = 180 mg/dL). 12. Individuals whose AST (GOT) or ALT (GPT) levels are = 2 times the upper limit of the normal range at the study site. 13. Individuals whose serum creatinine levels are = 2 times the upper limit of the normal range at the study site. 14. Patients suspected of having an underlying organic disease. 15. Patients with moderate systemic complications involving organs other than the heart, liver, or kidneys. 16. Patients with psychogenic disorders. 17. Individuals with an implanted cardiac pacemaker. 18. Patients with inflammation, infection, wounds, or other lesions at the planned pharmacopuncture sites that would prevent safe administration. 19. Patients within 3 months after lumbar spine surgery. 20. 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. 21. Any individual deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain numeric rating scale, NRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Low back pain and radiating leg pain numeric rating scale, NRS;low back pain and radiating leg pain visual analogue scale, VAS;Oswestry Disability Index, ODI;Korean version of the Roland–Morris Disability Questionnaire, RMDQ-6;Patient Global Impression of Change, PGIC;EQ-5D-5L, HINT-8;Credibility and Expectancy;Drug consumption;Economic evaluation variables;Work Productivity and Activity Impairment Questionnaire (WPAI) | — |
Countries
Korea, Republic of
Contacts
Public ContactSuwon Lee
Jaseng Medical Foundation
Outcome results
None listed