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

2019-09-15 03:11:26 | BioPortfolio

Summary

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

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 Design

Conditions

Temporomandibular Disorder

Intervention

hominis placental pharmacopuncture

Location

Jaseng Hospital of Korean Medicine
Seoul
Gangnam-Gu
Korea, Republic of
135-896

Status

Not yet recruiting

Source

Jaseng Medical Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-15T03:11:26-0400

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