Temporomandibular DisorderPhase 2/3TMD ECa233NCT06231212
Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
A Phase 2/3 study testing ECa 233 and Ibuprofen in people with Temporomandibular Disorder, run by Chulalongkorn University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- ECa 233 and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteThailand
- Study dates
- 5 Aug 2020to 30 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Temporomandibular Disorder
- Being tested
- ECa 233, Ibuprofen, Placebo
- Keywords
- TMD
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECa 233Drug
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.
IbuprofenDrug
Also called NSAIDs
Ibuprofen group was given capsules containing 200 mg of ibuprofen
PlaceboOther
Also called lactose
Placebo-controlled group received capsules containing 250 mg of lactose
| Study group | Role | What they receive |
|---|---|---|
| ECa groups | Experimental | Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside Receives: Drug: ECa 233 |
| NSAID group | Active comparator | Active-controlled group was given capsules containing 200 mg of ibuprofen Receives: Drug: Ibuprofen |
| Placebo group | Placebo comparator | Placebo-controlled group received capsules containing 250 mg of lactose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days
Efficacy of ECa 233 capsules for jaw function
Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start5 Aug 2020
- Primary completion1 Sep 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prangtip Potewiratnanond D.D.S, M.Sc., Ph.D., Chulalongkorn University
- Investigators
- Prangtip Potewiratnanond, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231212
- Sponsor's protocol ID
- CRP6305031970
- Acronym
- TMD ECa233
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40253389
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT06231212
- Acronym / sponsor ID
- TMD ECa233 / CRP6305031970
- Conditions
- Temporomandibular Disorder
- Keywords
- TMD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| ECa groups | Experimental | Drug: ECa 233Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside |
| NSAID group | Active comparator | Drug: IbuprofenActive-controlled group was given capsules containing 200 mg of ibuprofen |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo-controlled group received capsules containing 250 mg of lactose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECa 233Intervention 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. | Drug | ECa groups |
| IbuprofenAlso: NSAIDsIbuprofen group was given capsules containing 200 mg of ibuprofen | Drug | NSAID group |
| PlaceboAlso: lactosePlacebo-controlled group received capsules containing 250 mg of lactose | Other | Placebo group |
Primary outcome
Efficacy of ECa 233 for pain intensity
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 40253389Potewiratnanond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prangtip Potewiratnanond principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ECa 233 and Ibuprofen in people with Temporomandibular Disorder, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ECa 233 for pain intensity (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06231212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.