Trial studying safety and effects for Chronic Low Back Pain (CLBP)
Official title Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07304076
What this study is testing
What is Hominis placental pharmacopuncture (JHG002)?
This is an investigational injectable extract being studied to see if it helps with chronic low back pain.
Also referred to as JHG002.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if JHG002 works better than other options and is safe for treating chronic low back pain.
- Who it's for
- The study is looking for adults who have long-term lower back pain.
- What's involved
- Participants will receive either the JHG002 treatment or a standard option and undergo regular check-ups and tests to monitor their health.
- Time commitment
- The source text does not specify the duration or number of visits required.
- Time commitment: about 5 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70
You may be able to join if
- 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.
You likely can't join if
- Patients diagnosed with serious underlying conditions that may cause low back pain, such as spinal metastasis of malignancy, acute vertebral...
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Seoul, Gangdong-gu, South Korea
- Seoul, Gangnam-Gu, South Korea
- Bucheon-si, GGyeonggi-do, South Korea
- Seongnam, GGyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seoul, Gangdong-gu, South Korea; Seoul, Gangnam-Gu, South Korea; Bucheon-si, GGyeonggi-do, South Korea; Seongnam, GGyeonggi-do, South Korea. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.