Clinical trial NCT06231212: Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
Official title: Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Disorder
Keywords: TMD
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 (out of 10) of pain intensity on a numerical rating scale (NRS). No medications were self-reported 24 hours 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, were recorded at baseline and 7 and 14 days post-treatment. Masticatory muscle and jaw joint tenderness were evaluated upon palpation according to the Diagnostic Criteria for TMD (DC/TMD).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of ECa 233 for pain intensity
timeFrame: 14 days
measure: Efficacy of ECa 233 capsules for jaw function
timeFrame: 14 days
measure: Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Prangtip Potewiratnanond
role: PRINCIPAL_INVESTIGATOR
References: