Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed 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.
    

Intervention name(s): ECa 233; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intervention groups are separated into group A and group B. Group A takes capsules containing 250 mg of ECa 233 and group B takes capsules containing 500 mg of ECa 233.; Ibuprofen group was given capsules containing 200 mg of ibuprofen; Placebo-controlled group received capsules containing 250 mg of lactose
Other intervention name(s): NSAIDs; lactose
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: 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 (out of 10) of pain intensity on a numerical rating scale (NRS). No medications were self-reported 24 hours 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, were recorded at baseline and 7 and 14 days post-treatment. Masticatory muscle and jaw joint tenderness were evaluated upon palpation according to the Diagnostic Criteria for TMD (DC/TMD).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TMD