NCT04087005

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

Efficacy and Safety of JHG002(Hominis Placenta, 紫河車) Therapy for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.

Detailed description

From 2 hospitals of Korean medicine, we will enrol 82 chronic TMD patients in Axis 1, Group Ⅰ according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be 4 follow-up visits (6, 9, 13, and 25 weeks from baseline). The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual analogue scale (VAS) score for temporomandibular pain between baseline and Week 6. Secondary outcomes will be Numeric rating scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, Korean version of Beck's Depression Index-Ⅱ(K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patien Global Impression of Change(PGIC), and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment).

Conditions

• Temporomandibular Disorder

Interventions

Type	Name	Description
OTHER	hominis placental pharmacopuncture	Hominis placental pharmacopuncture is human placental extract, which has been used in traditional Korean medicine to treat chronic diseases, including frailty, cough, anorexia, and fatigue, by enhancing the body's resistance.

Timeline

• Start date: 2019-10-17
• Primary completion: 2020-07-21
• Completion: 2020-07-21
• First posted: 2019-09-12
• Last updated: 2021-06-02

Locations

2 sites across 1 country: South Korea