Hominis placental pharmacopunctureTanscutaneous electrical nerve stimulation (TENS)
Hominis placental pharmacopuncture: JHG002 pharmacopuncture is a purified Hominis placenta extract formulated for injection at acupuncture points. In Korean medicine, Hominis placenta has traditionally been used to support vitality, relieve chronic pain, and enhance functional recovery.
Tanscutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve stimulation is a non-invasive physical therapy that delivers low-intensity electrical stimulation to the lumbar area to reduce pain and muscle tension.
Study summary
A multicenter randomized controlled trial
Eligibility
Sex
ALL
Min age
19 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in low back pain intensity (NRS) — Week 1, 2-5, 6, 9, 13, 25 The primary outcome is the change in low back pain intensity between baseline and Week 6. Low back pain severity during the past week will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on an 11-point scale ranging from 0 (no pain) to 10 (the worst pain imaginable). Participants will be instructed to report their average low back pain intensity over the past 7 days.
Trial sites (4)
Facility
City
Region
Status
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul
Gangdong-gu
Recruiting
Jaseng Hospital of Korean Medicine
Seoul
Gangnam-Gu
Recruiting
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si
GGyeonggi-do
Recruiting
Dongguk University Bundang Oriental Hospital
Seongnam
GGyeonggi-do
Recruiting
More Jaseng Medical Foundation trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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