Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT03728192
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2018-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-vitro Effect of Mangosteen Pericarp Extract on Cell Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002166', 'term': 'Camptothecin'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study comprised of two groups A (Hela) and group B ( H357) . Each group was further subdivided into 3 subgroups- A1 -Untreated cells, A2- mangosteen treated cells and A3- cells treated with standard drug. Group B was divided into B1- Untreated cells, B2- mangosteen treated cells and B3 -cells treated with the standard drug healthy periodontium. Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone los'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'apoptotic potential of ethanolic extract of mangosteen pericarp on oral and cervical cancer cell lines via apoptotic assay', 'timeFrame': '48 hrs at base line', 'description': 'Apoptosis assay was performed using Annexin V/FITC Kit (BD Biosciences, Catalog no. 556547), and the fluorescence intensities of FITC-conjugated annexin-V and Propidium iodide (PI) in cells were analyzed using flow cytometry. HeLa and H357 cells (1×106 cells/well) were seeded in a 6-well plate. The cells were allowed to adhere for 12 hrs, cultured in medium containing different concentrations of mangosteen extract for 48hr. The cells were then collected and washed twice with Phosphate buffer Saline, gently resuspended in 100μL annexinV-FITC binding buffer (1x) and incubated with 5μL annexinV-FITC in the dark for 10 min at 25°C. This was followed by centrifugation of cells at 2000 rpm for 5 min, and gently resuspended in 500μL annexinV-FITC binding buffer (1x) and 5μL PI was added in an ice bath, followed by immediate analysis by flow cytometry Cell Quest software (BD Biosciences).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apoptosis']}, 'descriptionModule': {'briefSummary': 'The present study is an effort to investigate the hypothesis that in-vitro vitality and antiapoptotic effect of alcoholic crude extract of mangosteen on Oral cancer( H357) cell lines and Cevical cancer (HeLa) cell lines.', 'detailedDescription': 'The oral and cervical cells were investigated by MTT (3-4,5- dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) assay, DNA fragmentation detection by TUNEL (Terminal deoxynucleotidyl transferase-mediated d-UTP Nick End Labeling) assay and Apototic assay using Annexin V/FITC Kit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with oral squamous cell carcinoma\n* Patients with cervical carcinoma\n\nExclusion Criteria:\n\n• Patients with leukaemia'}, 'identificationModule': {'nctId': 'NCT03728192', 'acronym': 'invitro', 'briefTitle': 'In-vitro Effect of Mangosteen Pericarp Extract on Cell Lines', 'organization': {'class': 'OTHER', 'fullName': 'Meenakshi Ammal Dental College and Hospital'}, 'officialTitle': 'Inhibition and Cytotoxic Effects of Mangosteen on Cell Lines', 'orgStudyIdInfo': {'id': 'MAHER-MU-004-IEC/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mangosteen treated group', 'description': 'HeLa and H357 cell lines were procured and were further subdivided into 2 subdivisions and were assigned interventions:\n\nMangosteen group- cells treated with mangosteen extract and Camptothecin group - cells treated with standard anticancer drug camptothecin(25 micro mole)', 'interventionNames': ['Other: mangosteen extract']}, {'type': 'NO_INTERVENTION', 'label': 'Untreated group', 'description': 'H357 and HeLa cell line without any drug intervention.'}], 'interventions': [{'name': 'mangosteen extract', 'type': 'OTHER', 'otherNames': ['camptothecin'], 'description': 'For Mangosteen group :DNA fragmentation assay is used to identify apoptosis.1×106 cells were harvested and treated with mangosteen pericarp extract for 48 h For Camptothecin group : Cells were also treated with standard anticancer drug Camptothecin to act as a positive control.', 'armGroupLabels': ['Mangosteen treated group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jaideep Mahendra, MDS,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meenakshi academy of higher education and research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meenakshi Ammal Dental College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of post graduate studies', 'investigatorFullName': 'Dr.Jaideep Mahendra', 'investigatorAffiliation': 'Meenakshi Ammal Dental College and Hospital'}}}}