Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 10:45 AM
Study NCT ID:
NCT05017467
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2021-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526146', 'term': 'Centella asiatica extract'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '280'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '280 operated patient with carpal tunnel release surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2021-04-10', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'centella asiatica extrate', 'timeFrame': '10 years', 'description': 'treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carpal tunnel syndrome', 'centella asiatica', 'surgery', 'cosmetic outcome', 'wound healing'], 'conditions': ['To Prevent Scar Formation for Patients Underwent Surgery']}, 'descriptionModule': {'briefSummary': 'The centella asiatica cream applied to the wrist after the CTR surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand.', 'detailedDescription': 'Aim: This study was performed to evaluate the efficacy of centella asiatica extract in a cream preparation for the prevention of scar tenderness formation in patients who underwent conventional open carpal tunnel release surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: patient underwent open carpal tunnel release surgery -\n\nExclusion Criteria:before hand surgery and recurrent carpal tunnel release surgery.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05017467', 'briefTitle': 'The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Konya Numune Hospital'}, 'officialTitle': 'The Effect of Centella Asiatica Cream on Scar Tenderness in Patients Who Underwent Open Carpal Tunnel Release Surgery', 'orgStudyIdInfo': {'id': 'B.10.4.ISM.4.42.00.14-8271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vss', 'description': 'Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery', 'interventionNames': ['Drug: undefinedCentella Asiatica Extract']}, {'type': 'EXPERIMENTAL', 'label': 'QuickDASH , VAS', 'description': ', Quick Disabilities of Arm Shoulder and Hand functional score (QuickDASH) and Visual Analogue Scale (VAS) test was used to determine overall hand function, activities of daily living, work performance, pain, aesthetics, and satisfaction with hand function', 'interventionNames': ['Drug: undefinedCentella Asiatica Extract']}], 'interventions': [{'name': 'undefinedCentella Asiatica Extract', 'type': 'DRUG', 'otherNames': ['centella asiatica extract'], 'description': 'All patients were asked about scar hypertrophy, scar tenderness, and pillar pain.\n\nThe scar assessment was performed using the Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery.\n\nPatients were asked to complete pre- and postoperative functional evaluations. The VAS score and QuickDASH test was used', 'armGroupLabels': ['QuickDASH , VAS', 'vss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42090', 'city': 'Konya', 'state': 'Meram', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa Balevi,MD', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'city': 'Konya', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Ali Balevi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İstanbul Medipol Üniversity,Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Balevi,MD', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Konya Numune Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Mustafa Balevi,MD', 'investigatorAffiliation': 'Konya Numune Hospital'}}}}