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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ethnopharmacological Studies in Oral Medicine

NCT00200837

Oral Pain Oral Ulcers Oral Tumors

COMPLETED

Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -

NCT03132974

Chronic Low Back Pain

UNKNOWN PHASE2/PHASE3

A Trial of Echinacea in Children

NCT00029211

Common Cold

COMPLETED PHASE3

Traditional Chinese Medicine (TCM) for Temporomandibular Dysfunction (TMD): A Whole Systems Multi-site Trial

NCT00856167

Temporomandibular Dysfunction

COMPLETED PHASE2

Echinaforce Junior Bioavailability Trial

NCT03070314

Common Cold

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ECa groups

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

Group Type EXPERIMENTAL

ECa 233

Intervention Type DRUG

Intervention groups are separated into group A and group B. Group A takes capsules containing 250 mg of ECa 233 and group B takes capsules containing 500 mg of ECa 233.

NSAID group

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen group was given capsules containing 200 mg of ibuprofen

Placebo group

Placebo-controlled group received capsules containing 250 mg of lactose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo-controlled group received capsules containing 250 mg of lactose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ECa 233

Intervention groups are separated into group A and group B. Group A takes capsules containing 250 mg of ECa 233 and group B takes capsules containing 500 mg of ECa 233.

Intervention Type DRUG

Ibuprofen

Ibuprofen group was given capsules containing 200 mg of ibuprofen

Intervention Type DRUG

Placebo

Placebo-controlled group received capsules containing 250 mg of lactose

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NSAIDs lactose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No