| Registry | NCT06231212, acronym TMD ECa233 |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, single group, masking: triple, treatment |
| Enrollment | 23 (Actual) |
| Sponsor | Chulalongkorn University (Other) |
| Conditions | Temporomandibular Disorder |
| Interventions | ECa 233, Ibuprofen, Placebo (Drug, other) |
| Dates | start 2020-08-05, primary completion 2021-09-01, completion 2022-12-30, first posted 2024-01-30, last updated 2024-02-07 |
| Locations | 1 site in Thailand |
Related Papers Related Patents Related Grants Related Experts
All trials for Temporomandibular Disorder All trials of ECa 233 All trials of Ibuprofen
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ECa groups | Experimental | Drug: ECa 233 | Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside |
| NSAID group | Active comparator | Drug: Ibuprofen | Active-controlled group was given capsules containing 200 mg of ibuprofen |
| Placebo group | Placebo comparator | Other: Placebo | Placebo-controlled group received capsules containing 250 mg of lactose |
Sex: All, ages: 18 Years to 55 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Chulalongkorn University | Bangkok | Thailand |