Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial

Inclusion Criteria: 1. Patients with unilateral or bilateral TMJ pain 2. Patients with VAS≥40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain) 3. Patients complaining of persistent of sporadic TMJ pain for at least 3 months 4. Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria\[5\] 5. Patients aged 19-70 years on the date they sign the consent form 6. Patients who provide consent to participate in the trial and return the informed consent form Exclusion Criteria: 1. Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury 2. Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria 3. Patients who have undergone surgery related to the TMJ 4. Patients with other chronic disease that could interfere with interpretation of the treatment effects or outcomes (e.g., rheumatoid arthritis, neoplastic disease, stroke, or myocardial infarction) 5. Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results 6. Patients who have received HPP within the last month, or who have taken drugs that could affect pain, such as NSAIDs, within the last week 7. Pregnant or breastfeeding women 8. Patients who have finished participation in another clinical trial within the last month, who participated in another trial within 6 months of selection, or who are planning to participate in another clinical trial during the follow-up period 9. Patients with a history of hypersensitivity after HPP 10. Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥180mg/dl) 11. Patients with AST (GOT) or ALT (GPT) at least 2 times the normal range at the testing centre 12. Patients with creatinine at least 2 times the normal range at the testing centre 13. Patients suspected to have organic disease 14. Patients with cardiac, hepatic, renal, or other serious complications 15. Patients with psychogenic disease 16. Patients who are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints 17. Other patients whose participation in the trial is judged by a researcher to be problematic