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

Phase 2

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Other: Placebo; Drug: ECa 233; Drug: Ibuprofen

• Registration Number: NCT06231212
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2020-08-05
• Primary Completion: 2021-09-01
• Study Completion: 2022-12-30
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo-controlled group received capsules containing 250 mg of lactose
ECa groups	ECa 233	Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside
NSAID group	Ibuprofen	Active-controlled group was given capsules containing 200 mg of ibuprofen

Primary Outcome Measures

Name	Time	Method
Efficacy of ECa 233 for pain intensity	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).
Efficacy of ECa 233 capsules for jaw function	14 days	Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,
Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation	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

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand