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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. Identifier: NCT03728192
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE March 7, 2016
Actual Primary Completion Date May 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE In-vitro Effect of Mangosteen Pericarp Extract on Cell Lines
Official Title  ICMJE Inhibition and Cytotoxic Effects of Mangosteen on Cell Lines
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Apoptosis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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)

    Intervention: Other: mangosteen extract
  • No Intervention: Untreated group
    H357 and HeLa cell line without any drug intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 13, 2018
Actual Primary Completion Date May 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with leukaemia

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03728192
Other Study ID Numbers  ICMJE MAHER-MU-004-IEC/2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
Study Sponsor  ICMJE Meenakshi Ammal Dental College and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaideep Mahendra, MDS,PhD Meenakshi academy of higher education and research
PRS Account Meenakshi Ammal Dental College and Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP