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

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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