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

NCT06231212 | Completed Phase 2 DMC

• 1 other identifier: CRP6305031970
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Keywords

TMD

Outcome Measures

Primary Outcomes (3)

• Efficacy of ECa 233 for pain intensity

  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).

  14 days

• Efficacy of ECa 233 capsules for jaw function

  Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,

  14 days

• Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation

  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

  14 days

Study Arms (3)

ECa groups

EXPERIMENTAL

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

Drug: ECa 233

NSAID group

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Placebo group

PLACEBO COMPARATOR

Placebo-controlled group received capsules containing 250 mg of lactose

Other: Placebo

Interventions

ECa 233 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.

ECa groups

Ibuprofen DRUG

Ibuprofen group was given capsules containing 200 mg of ibuprofen

Also known as: NSAIDs

NSAID group

Placebo OTHER

Placebo-controlled group received capsules containing 250 mg of lactose

Also known as: lactose

Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, Thailand

Location

Related Publications (1)

• Potewiratnanond P, Surarit R, Tantisira MH, Samaranayake L, Rotpenpian N, Wanasuntronwong A. Efficacy of Centella asiatica on mitigating temporomandibular pain and improving functionality: a randomized, double blind, pilot clinical trial. Head Face Med. 2025 Apr 19;21(1):28. doi: 10.1186/s13005-025-00503-y.

  PMID: 40253389 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

ECa 233 extract; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Lactose

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Prangtip Potewiratnanond

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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).

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: August 5, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 30, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

TH (1)