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Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
Led by Jaseng Medical Foundation · Updated on 2026-02-25
96
Participants Needed
4
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter randomized controlled trial
CONDITIONS
Official Title
Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 69 years at the time of signing the informed consent.
- Low back pain lasting 6 months or longer, with continuous or intermittent symptoms.
- Numeric Rating Scale (NRS) score of 5 or higher for low back pain at screening.
- Ability to understand the trial procedures and voluntarily agree to participate by providing written informed consent.
You will not qualify if you...
- Diagnosed serious conditions causing low back pain such as spinal metastasis, acute vertebral fracture, or spinal dislocation.
- Progressive neurological deficits or severe neurological symptoms.
- Pain caused by non-spinal soft tissue disorders like tumors, fibromyalgia, rheumatoid arthritis, or gout.
- Other chronic medical conditions that could affect treatment response or study outcomes, including stroke, myocardial infarction, chronic kidney disease, diabetic neuropathy, dementia, or epilepsy.
- Current use of corticosteroids, immunosuppressants, psychiatric medications, or other drugs affecting study results.
- Conditions making pharmacopuncture unsafe, including bleeding disorders or anticoagulant therapy.
- Use of analgesic medications such as NSAIDs or pharmacopuncture within the past week.
- Women of childbearing potential not willing to use acceptable contraception during the study.
- Pregnant or breastfeeding women.
- History of allergic reactions to Hominis placenta pharmacopuncture (JHG002).
- Uncontrolled diabetes with fasting blood glucose 180 mg/dL or higher.
- Elevated liver enzymes (AST or ALT) or serum creatinine at twice the upper normal limit.
- Suspected underlying organic disease.
- Moderate systemic complications involving organs other than heart, liver, or kidneys.
- Psychogenic disorders.
- Presence of an implanted cardiac pacemaker.
- Inflammation, infection, wounds, or lesions at planned pharmacopuncture sites.
- Lumbar spine surgery within the past 3 months.
- Participation in another clinical trial within the past month or planned participation within 6 months.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea, 05278
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2
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 06110
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3
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, South Korea, 14598
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4
Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-do, South Korea, 13601
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Research Team
I
In-Hyuk Ha, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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