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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

RecruitingNot applicableNCT07304076
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

A multicenter randomized controlled trial

Study details

Official title
Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
Interventions
  • Drug: Hominis placental pharmacopuncture
  • Device: Tanscutaneous electrical nerve stimulation (TENS)
Sponsor
Jaseng Medical Foundation
Start date
2025-12-17
Primary completion
2029-11-28
Sex
All
Age range
from 19 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 c…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07304076