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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECa groups | Experimental | Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside |
|
| NSAID group | Active Comparator | Active-controlled group was given capsules containing 200 mg of ibuprofen |
|
| Placebo group | Placebo Comparator | Placebo-controlled group received capsules containing 250 mg of lactose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Prangtip Potewiratnanond | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40253389 | Derived | 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. |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000591488 | ECa 233 extract |
| D007052 | Ibuprofen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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).
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| Ibuprofen | Drug | Ibuprofen group was given capsules containing 200 mg of ibuprofen |
|
|
| Placebo | Other | Placebo-controlled group received capsules containing 250 mg of lactose |
|
|
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D018712 |
| Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |