NCT03728192

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

July 13, 2018

Last Update Submit

October 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • apoptotic potential of ethanolic extract of mangosteen pericarp on oral and cervical cancer cell lines via apoptotic assay

    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).

    48 hrs at base line

Study Arms (2)

Mangosteen treated group

EXPERIMENTAL

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

Untreated group

NO INTERVENTION

H357 and HeLa cell line without any drug intervention.

Interventions

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.

Also known as: camptothecin
Mangosteen treated group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with leukaemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Camptothecin

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Jaideep Mahendra, MDS,PhD

    Meenakshi academy of higher education and research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of post graduate studies

Study Record Dates

First Submitted

July 13, 2018

First Posted

November 2, 2018

Study Start

March 7, 2016

Primary Completion

May 11, 2016

Study Completion

July 13, 2018

Last Updated

November 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share