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

NCT06231212 — Phase 2 / Phase 3, Completed, 23 participants, Chulalongkorn University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT06231212, acronym TMD ECa233
StatusCompleted
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, single group, masking: triple, treatment
Enrollment23 (Actual)
SponsorChulalongkorn University (Other)
ConditionsTemporomandibular Disorder
InterventionsECa 233, Ibuprofen, Placebo (Drug, other)
Datesstart 2020-08-05, primary completion 2021-09-01, completion 2022-12-30, first posted 2024-01-30, last updated 2024-02-07
Locations1 site in Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Temporomandibular Disorder All trials of ECa 233 All trials of Ibuprofen

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
ECa groupsExperimentalDrug: ECa 233Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside
NSAID groupActive comparatorDrug: IbuprofenActive-controlled group was given capsules containing 200 mg of ibuprofen
Placebo groupPlacebo comparatorOther: PlaceboPlacebo-controlled group received capsules containing 250 mg of lactose
  • ECa 233 (Drug): 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 (Drug), also known as NSAIDs: Ibuprofen group was given capsules containing 200 mg of ibuprofen
  • Placebo (Other), also known as lactose: Placebo-controlled group received capsules containing 250 mg of lactose

+Outcome measures

Primary outcomes

  • Efficacy of ECa 233 for pain intensity [14 days]: The pain intensity self-reported levels and other clinical parameters were collected at 3 time points: pre-intervention (baseline), 7 and 14 days post-intervention. The pain intensity score was determined by using a 10-point ordinal scale (0 representing no pain and 10 indicating severe pain).
  • Efficacy of ECa 233 capsules for jaw function [14 days]: Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,
  • Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation [14 days]: The number of masticatory muscles and TMJs with pain upon palpation were counted on the left and right sides. The total score ranged from 0-12 locations

+Eligibility

Sex: All, ages: 18 Years to 55 Years

Inclusion criteria

* Subjects reporting TMD pain lasting for 30 days or less (acute pain)
* Subjects with pain ratings between 5 and 8 on a 0-10 numerical rating scale

Exclusion criteria

* Subjects with any underlying chronic disease
* Subjects undergo any sort of treatment that may influence pain perception and/or inflammation, including as diabetes, psychological distress, systemic inflammatory disorders, oral appliances, and medications

+Locations (1)

FacilityCityCountryStatus
Chulalongkorn UniversityBangkokThailand

+Publications

  • Results publication: Potewiratnanond P, Surarit R, Tantisira MH, Samaranayake L, Rotpenpian N, Wanasuntronwong A. Efficacy of Centella asiatica on mitigating temporomandibular pain and improving functionality: a randomized, double blind, pilot clinical trial. Head Face Med. 2025 Apr 19;21(1):28. doi: 10.1186/s13005-025-00503-y. PMID 40253389

+Investigators