- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288298
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line
September 18, 2017 updated by: Safaa Elbaz, Cairo University
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study
In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.
The primary outcome is apoptosis, while the secondary outcome is cell viability.
Study Type
Interventional
Enrollment (Anticipated)
4
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Safaa M. Baz, Masters
- Phone Number: 002 01119777824
- Email: drsafaaelbaz@gmail.com
Study Contact Backup
- Name: Safa F. Abd El-Ghani, PhD
- Phone Number: 002 01005198010
- Email: drsafa.fathy@yahoo.com
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:
- Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC).
- Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term).
- Application of luteolin as a chemotherapeutic drug.
Exclusion Criteria:
- Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
- Luteolin glycosides.
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: luteolin
a natural extract derived flavinoids
|
flavonoid natural extract
Other Names:
|
Active Comparator: nano-luteolin
nano-particles derived from a natural extract luteolin
|
nanoparticles of luteolin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gene expression of Caspase 3 to detect apoptosis
Time Frame: 6 hours
|
fold-changes
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cell viability
Time Frame: 6 hours
|
micromolar
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ahmed Elkhadem, PhD, Center for Evidence Based Dentistry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Anticipated)
November 1, 2017
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
September 12, 2017
First Submitted That Met QC Criteria
September 18, 2017
First Posted (Actual)
September 20, 2017
Study Record Updates
Last Update Posted (Actual)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 18, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2017-09-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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