Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06231212
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2024-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591488', 'term': 'ECa 233 extract'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2024-01-21', 'studyFirstSubmitQcDate': '2024-01-21', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of ECa 233 for pain intensity', 'timeFrame': '14 days', 'description': '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).'}, {'measure': 'Efficacy of ECa 233 capsules for jaw function', 'timeFrame': '14 days', 'description': 'Mandibular range of motion, including pain-free, unassisted and assisted mouth opening,'}, {'measure': 'Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation', 'timeFrame': '14 days', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TMD'], 'conditions': ['Temporomandibular Disorder']}, 'referencesModule': {'references': [{'pmid': '40253389', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Can ECa 233 reduce pain intensity score in subjects with acute TMD?\n* 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Subjects reporting TMD pain lasting for 30 days or less (acute pain)\n* Subjects with pain ratings between 5 and 8 on a 0-10 numerical rating scale\n\nExclusion criteria\n\n* Subjects with any underlying chronic disease\n* 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'}, 'identificationModule': {'nctId': 'NCT06231212', 'acronym': 'TMD ECa233', 'briefTitle': 'Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder', 'orgStudyIdInfo': {'id': 'CRP6305031970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECa groups', 'description': 'Intervention group takes capsules containing of ECa 233, an active substance composed of Madecassoside and Asiaticoside', 'interventionNames': ['Drug: ECa 233']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSAID group', 'description': 'Active-controlled group was given capsules containing 200 mg of ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo-controlled group received capsules containing 250 mg of lactose', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'ECa 233', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['ECa groups']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['NSAIDs'], 'description': 'Ibuprofen group was given capsules containing 200 mg of ibuprofen', 'armGroupLabels': ['NSAID group']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['lactose'], 'description': 'Placebo-controlled group received capsules containing 250 mg of lactose', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Prangtip Potewiratnanond', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Prangtip Potewiratnanond D.D.S, M.Sc., Ph.D.', 'investigatorAffiliation': 'Chulalongkorn University'}}}}