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

Temporomandibular Disorder Clinical Trial

— TMD ECa233  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06231212
• Other study ID #: CRP6305031970
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 5, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 30, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• ECa 233
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
Ibuprofen group was given capsules containing 200 mg of ibuprofen

Other:
• Placebo
Placebo-controlled group received capsules containing 250 mg of lactose

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ECa 233 for pain intensity	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).	14 days
Primary	Efficacy of ECa 233 capsules for jaw function	Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,	14 days
Primary	Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation	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	14 days