Development of Formulation Loaded with Polyphenols for the Treatment of Oral Submucous Fibrosis
Not Applicable
Completed
- Conditions
- Health Condition 1: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2021/11/037819
- Lead Sponsor
- Manipal College of Pharmaceutical Sciences MAHE Manipal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Inclusion Criteria
Tissues can be included or taken from the patients who confirmed with oral submucous fibrosis (OSMF, disease control) disease and patients without OSMF (normal control). Also, Fibrous bands along the buccal mucosa on clinical examination; histopathological confirmation of punch biopsy.
Exclusion Criteria
Patients confirmed with oral cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As the OSMF condition increasing day by day, effective treatment strategies are required. In this study, the efficacy of the drug and formulation will be checked on the cells harvested from the biopsy tissue sample which can be used for checking efficacy and cytotoxicity.Timepoint: The tissue will be collected from the patients using biopsy technique and same will be used for the harvesting of cells from collected biopsy tissue sample which requires minimum of 2 to 3 weeks.
- Secondary Outcome Measures
Name Time Method The generated cells will be used for testing the efficacy of selected polyphenols and prepared formulation of loaded polyphenol by performing the cytotoxicity studies and gene expression study. The cells will be incubated for 72 hrs. for cytotoxicity and gene expression studies. Once the incubation period finished, the cells will used for analyzing the cytotoxicity and expression of genes.Timepoint: The efficacy of the polyphenols and formulation on cells harvested from the biopsy tissue sample and same has been used for the gene expression studies which requires incubation period for almost 72 hrs (3 days).