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In-vitro Effect of Mangosteen Pericarp Extract on Cell Lines (invitro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728192
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Apoptosis Other: mangosteen extract Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Inhibition and Cytotoxic Effects of Mangosteen on Cell Lines
Actual Study Start Date : March 7, 2016
Actual Primary Completion Date : May 11, 2016
Actual Study Completion Date : July 13, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mangosteen treated group

HeLa and H357 cell lines were procured and were further subdivided into 2 subdivisions and were assigned interventions:

Mangosteen group- cells treated with mangosteen extract and Camptothecin group - cells treated with standard anticancer drug camptothecin(25 micro mole)

 Other: mangosteen extract
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.
Other Name: camptothecin
No Intervention: Untreated group
H357 and HeLa cell line without any drug intervention.


Outcome Measures
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Primary Outcome Measures :
  1. apoptotic potential of ethanolic extract of mangosteen pericarp on oral and cervical cancer cell lines via apoptotic assay [ Time Frame: 48 hrs at base line ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with oral squamous cell carcinoma
  • Patients with cervical carcinoma

Exclusion Criteria:

• Patients with leukaemia

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728192


Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Principal Investigator: Jaideep Mahendra, MDS,PhD Meenakshi academy of higher education and research
More Information
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Responsible Party: Dr.Jaideep Mahendra, Director of post graduate studies, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT03728192    
Other Study ID Numbers: MAHER-MU-004-IEC/2016
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action