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Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder — TMD ECa233  

Temporomandibular Disorder Clinical Trial

Official title:
Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder

Clinical Trial Summary

The goal of this clinical trial is to test analgesic effect of ECa 233 in subjects with TMD. The main questions it aims to answer are: - Can ECa 233 reduce pain intensity score in subjects with acute TMD? - Can ECa 233 increase jaw functional movements in subjects with acute TMD? Participants will be separated into four groups, including placebo, ibuprofen, low-dosed Eca and high-dosed Eca groups.

Clinical Trial Description

ECa 233 is a standardized extract of Centella asiatica with known anti-inflammatory properties and an acceptable safety profile. Hence, it would be relevant to evaluate the anti-inflammatory and pain reducing effects of ECa 233 on subjects with acute TMD, as well as jaw functional movements. A randomized, double-blind, placebo- and active-controlled clinical trial was performed on 18 to 50-year-old participants with acute TMD. These were randomly assigned to four treatment groups for 14 days: placebo, ibuprofen, ECa 233 250mg and 500 mg. At baseline, subjects reported 5 to 8 of pain intensity on a numerical rating scale (NRS). No medications were self-reported 24 h before and during the trial and no systemic conditions were diagnosed. Degenerative joint disease was screened before treatment. Pain intensity levels, mandibular range of motion including pain-free, unassisted and assisted mouth opening at baseline and days7 and 14 post-treatment. Masticatory muscle and jaw joint tenderness were evaluated upon palpation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06231212
Study type Interventional
Source Chulalongkorn University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date August 5, 2020
Completion date December 30, 2022
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