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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


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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