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Completed

NCT Number: NCT06231212

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

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chulalongkorn University

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Ibuprofen group was given capsules containing 200 mg of ibuprofen

Other names: NSAIDs

Placebo

Other

Placebo-controlled group received capsules containing 250 mg of lactose

Other names: lactose

Primary outcomes

  1. Efficacy of ECa 233 for pain intensity

    Time frame: 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).

  2. Efficacy of ECa 233 capsules for jaw function

    Time frame: 14 days

    Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,

  3. Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Acronym: TMD ECa233

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 30, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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