Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder (TMD ECa233)

Chulalongkorn University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Temporomandibular Disorder

Treatments: Drug: ECa 233; Other: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT06231212

CRP6305031970

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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23 participants in 3 patient groups, including a placebo group

ECa groups

Experimental group

Description:

Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside

Treatment:

Drug: ECa 233

NSAID group

Active Comparator group

Description:

Active-controlled group was given capsules containing 200 mg of ibuprofen

Treatment:

Drug: Ibuprofen

Placebo group

Placebo Comparator group

Description:

Placebo-controlled group received capsules containing 250 mg of lactose

Treatment:

Other: Placebo