Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-05 @ 10:43 AM
Study NCT ID:
NCT04087005
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2019-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial
Sponsor:
Jaseng Medical Foundation
Organization:
Study Overview
Official Title:
Efficacy and Safety of JHG002(Hominis Placenta, 紫河車) Therapy for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial)
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: