- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728192
In-vitro Effect of Mangosteen Pericarp Extract on Cell Lines (invitro)
October 30, 2018 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
Inhibition and Cytotoxic Effects of Mangosteen on Cell Lines
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.
Study Overview
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
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with oral squamous cell carcinoma
- Patients with cervical carcinoma
Exclusion Criteria:
• Patients with leukaemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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) |
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 Names:
|
No Intervention: Untreated group
H357 and HeLa cell line without any drug intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
48 hrs at base line
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jaideep Mahendra, MDS,PhD, Meenakshi academy of higher education and research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2016
Primary Completion (Actual)
May 11, 2016
Study Completion (Actual)
July 13, 2018
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
October 30, 2018
First Posted (Actual)
November 2, 2018
Study Record Updates
Last Update Posted (Actual)
November 2, 2018
Last Update Submitted That Met QC Criteria
October 30, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAHER-MU-004-IEC/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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